FDA Cleared, Approved or Registered? Claims Audit (2026)

TL;DR

"Approved" is the exception in the device world. In FDA's July 2026 registration and listing snapshot, 3,394 of 222,153 distinct establishment and product-code listing pairs (1.5%) sit under product codes that require premarket approval [1]. From 2015 to 2025, FDA recorded 33,491 substantially equivalent 510(k) decisions, 386 original PMA approvals and 343 De Novo grants; approvals were 1.1% of those decisions [2][3][4]. These are pathway-record counts, not the share of companies or marketed products entitled to use an approval claim. The right wording follows the exact product decision.

The bounded website crawl found little FDA status language in the pages it reached. On 12 September 2026, VayoMed crawled the 188 life-sciences domains it tracks and read the home page plus up to three internal pages of the 160 that responded. Nineteen sites (11.9%) used any FDA status phrase, and most of the "approved" wording belonged to companies with original PMA records or to drug approvals [5]. The separate, keyword-selected press-release sample showed a different pattern: in 702 PR Newswire releases, none of 178 headlines about a 510(k) said "approved", but 2 of 57 De Novo releases called the device "FDA approved", 23 of them used "cleared", and 142 of 151 releases that said "FDA registered" cited no premarket decision at all [6]. Google AI Mode used "approved" in 9 of 14 answers to device-category questions, usually inside the hedge "cleared or approved" [7].

Enforcement is real and episodic. Among 3,643 warning letters posted from January 2021 to July 2026, 26 device letters quote "approved", "registered", "certified" or "cleared" wording as false or misleading; 19 date from 2021, and the count after 2021 is zero to two letters per observed year [8]. The practical move is one wording standard per pathway, applied first to releases and distributor pages, then to the site, with the K, DEN or P number next to every claim, because the copies outlive the correction.

Why the wording is a growth-engine question, not a footnote

Search-volume estimates show interest in the distinction, alongside product-specific research. In the United States, "fda cleared vs fda approved" has an estimated 1,600 monthly searches; "fda registered vs fda approved" draws 170, "fda cleared meaning" 90 and "fda registered meaning" 20 [9]. The keyword data do not identify who searched or whether they subsequently visited a manufacturer; these queries are relevant to the terminology those audiences encounter.

The answer to that question is currently owned by FDA and by explainers. Across the 24 Google AI Mode answers in our probe, fda.gov pages were cited in 21, an industry blog and a clinical research firm's explainer in five each, LinkedIn posts in four and a law-firm page in two [7]. Manufacturer domains supplied none of the definition citations. The category answers contain both status claims and explanatory wording; causal attribution to particular sources remains unresolved.

The commercial exposure is replication. A release that calls a 510(k) device "FDA approved" is syndicated, quoted by distributors and summarized by answer engines; the site can be corrected in an afternoon, the copies stay. Two regulations define the boundary. Under 21 CFR 807.97, a representation that creates an impression of official approval because a device complied with premarket notification is misleading and constitutes misbranding, and 21 CFR 807.39 applies the same rule to representations based on establishment registration or a registration number [10][11]. This article treats that boundary as regulatory wording risk and identifies wording for product-level review.

"Approved" is the exception: what FDA's own records say

Three FDA exports and the De Novo database show the relative volume of selected regulatory records. The July 2026 product classification file lists 7,084 product codes: 3,213 (45.4%) require a 510(k), 2,638 (37.2%) are 510(k)-exempt and 501 (7.1%) require premarket approval. The remainder are 306 codes under enforcement discretion, 113 that direct the sponsor to contact FDA, 57 humanitarian device exemption codes, 42 emergency-use codes and 214 with no assignment [12].

Listings show what companies handle. The registration and listing export contains 419,651 processed rows that resolve to 222,153 distinct establishment and product-code pairs across 25,420 registered establishments [1]. A listing pair is a declaration that an establishment manufactures, develops, packages or distributes a product code; it is a record, and it says nothing about units sold.

Of those pairs, 135,638 (61.1%) sit under 510(k)-exempt codes and 76,213 (34.3%) under codes that require a 510(k). Codes that require premarket approval account for 3,394 pairs (1.5%). Enforcement-discretion codes cover 6,207 (2.8%), and emergency-use, contact-FDA and HDE codes together cover fewer than 700 [1]. The establishment view is sharper still: 1,307 of 25,420 establishments (5.1%) list at least one PMA-type product code, 12,648 (49.8%) list 510(k)-type codes with no PMA type, and 11,239 (44.2%) list exempt-type codes only [1].

Annual decisions tell the same story year after year. The 510(k) export records 172,003 substantially equivalent decisions since 1976; the PMA export holds 56,765 records, of which 1,471 are original PMAs and 55,294 are supplements to existing approvals, led by 30,697 process changes and 11,577 design changes [2][3]. The De Novo database lists 494 grants from 1998 to 3 September 2026 [4].

Across the eleven years, FDA cleared about 3,045 devices a year through 510(k), approved about 35 original PMAs a year and granted about 31 De Novo requests a year. Original PMA approvals were 1.1% of these 34,220 selected decisions; the denominator excludes PMA supplements, HDEs and EUAs [2][3][4]. The partial 2026 export shows the same proportions: 1,746 clearances and 24 original approvals through 22 July, and 25 De Novo grants through 3 September [2][3][4].

The long-run record agrees. Darrow, Avorn and Kesselheim, reviewing FDA device regulation from 1976 to 2020 in JAMA, report that from 1987 to 2020 the annual number of novel devices granted premarket approval ranged from 8 to 56 (median 32) while 510(k) clearances ranged from 2,804 to 5,762 (median 3,404) [13]. The operating premise for a commercial team follows directly: unless the company can cite an original P number or an H number for the product in question, "approved" is unsupported. VayoMed's earlier after-510(k) commercial readiness audit treated that distinction as a background sentence; here it is the base rate everything else is measured against.

What each status means, in the regulator's words

Regulatory wording risk arises when copy borrows the standard of one pathway for a product that came through another. The safest source of phrasing is the regulation and FDA's own pages, quoted with their conditions.

510(k): cleared, with a K number

A 510(k) is a premarket submission that shows a device is substantially equivalent to a legally marketed predicate; FDA describes premarket approval, by contrast, as its most stringent device application, based on valid scientific evidence that the device is safe and effective for its intended use [14]. The misbranding rule is explicit. Under 21 CFR 807.97, submission of a premarket notification and a determination of substantial equivalence "does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding" [10].

The evidentiary gap behind the wording is documented. In a systematic review of 1,000 devices randomly drawn from the 6,152 cleared in 2013 and 2014, Shah and colleagues found published research for 17.8% of them [15]. The study measures available published research; the evidence in a full FDA submission requires a separate assessment. The clearance/approval wording distinction follows the legal pathway itself. The accurate phrase is "FDA cleared" or "received 510(k) clearance for [indication]", published with the K number, the decision date and the cleared indications for use.

De Novo: granted, with a DEN number

The De Novo process classifies a novel low- or moderate-risk device into class I or II when no legally marketed predicate exists, either after a not-substantially-equivalent decision or directly [16]. FDA's formal act is an order granting the request; the device then becomes legally marketed and can serve as a predicate for later 510(k)s [4]. The accurate phrase is "FDA granted De Novo marketing authorization for [indication]", with the DEN number and the special controls. "Approved" overstates the decision; "cleared" describes a different pathway and belongs only to a later 510(k) on the same product line.

PMA and HDE: approved, with a P or H number

For PMA devices, use "FDA approved for [indication]" with the P number and the relevant original or supplement decision. For an HDE, explicitly say "FDA approved under a Humanitarian Device Exemption" and retain its humanitarian-use limits. HDE approval uses a probable-benefit standard and is exempt from PMA effectiveness requirements. [14][17] Supplements can authorize significant changes or new indications to an approved PMA. Identify exactly what the supplement approved; the export's 55,294 supplements and 1,471 originals represent different types of decisions [3].

Exempt, registered and listed: no premarket decision to cite

Most class I and some class II devices are exempt from 510(k) requirements, subject to the limitations in their classification regulations, and they remain subject to other regulatory controls [18]. Registration and listing duties still depend on the establishment's activity and the applicable exemptions. The regulation is unambiguous about what that record means. Under 21 CFR 807.39, registration or assignment of a registration number "does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding" [11]. The accurate phrase is "class [I or II] device exempt from premarket notification; establishment registered and device listed with FDA", with the registration number and product code.

Emergency Use Authorization: authorized, for now

Under section 564 of the Food, Drug, and Cosmetic Act, FDA may authorize unapproved medical products, or unapproved uses of approved products, for use during a declared emergency when the statutory criteria are met [19]. An EUA is therefore neither a clearance nor an approval, and it can be revoked. The accurate phrase is "FDA authorized for emergency use under an EUA for [use]", with the letter date, the authorized scope and the current status.

Breakthrough Device designation: a review status

The Breakthrough Devices Program speeds development, assessment and review "for premarket approval, 510(k) clearance, and De Novo marketing authorization"; designated devices "must meet the FDA's rigorous standards for device safety and effectiveness" before they are authorized for marketing, and FDA generally keeps a designation confidential until marketing authorization unless the sponsor discloses it [20]. As of 30 June 2026, 210 designated devices had received marketing authorization, 205 through CDRH and five through CBER [20]. The accurate phrase names the designation and states that marketing authorization is pending or names the later decision. "Breakthrough approval" conflates designation with the later marketing decision.

The certificate that FDA never issues

FDA's consumer page on the phrases "FDA registered" and "FDA certified" states that a registration and listing entry denotes no approval, clearance or authorization of the facility or its devices, that FDA issues no device registration certificates of any type, and that firms which display such certificates beside a device for sale to imply FDA review or approval misbrand the device [21]. In March 2021 FDA asked the firms producing these documents to stop, observing that a listing entry indicates only that the establishment has provided certain information and that a certificate appears to serve no purpose other than to imply approval, clearance, authorization, certification or endorsement [22]. For the marketing-status claims examined here, "FDA certified" is not a substitute for a clearance, approval or authorization.

The matrix condenses these rules into one row per pathway: the phrase to write, the phrases to remove, the identifier to publish and the regulatory basis. It is the standard the rest of this article tests the market against.

What 188 MedTech websites actually say

The cohort is the same 188-domain tracking list behind VayoMed's AI Visibility Reports: 119 medical device companies, 42 diagnostics companies, 20 imaging companies and seven other life-sciences businesses, the cohort VayoMed measured for crawler access and structured data in its website AI readability audit one week earlier [5]. On 12 September 2026 the crawl requested each home page with a browser-identified curl request, followed redirects, and then fetched up to three internal pages chosen by path keywords for company, product, news and regulatory sections. It read initial HTML only.

Of the 188 domains, 160 returned a usable home page and 529 pages were parsed; 103 sites yielded four pages, 25 three, 10 two and 22 the home page only. The 28 failures were 12 large sites answering 403 or a bot challenge, five domains that never connected and 11 redirects or empty bodies. Twenty-seven reachable sites were mostly Chinese or Japanese text, which lowers phrase recall for them [5].

Status language is scarce on these pages. Nineteen of 160 sites (11.9%) used any FDA status phrase. "FDA cleared" or "510(k) clearance" appeared on 13 sites (59 mentions), "FDA approved" on eight (15 mentions), EUA or "FDA authorized" on four, "FDA registered" on two, "FDA compliant" on one, and "FDA certified" and "FDA listed" on none. ISO 13485 appeared on 21 sites and CE marking on four; De Novo and Breakthrough designation each appeared on two [5]. Where the FDA phrases occurred, they sat inside news cards, milestone timelines and product pages rather than in company descriptions.

To screen claims for follow-up, each brand name and its documented aliases were matched by token containment against 510(k) applicants, original PMA applicants and De Novo requesters. The match found at least one 510(k) for 146 companies (26,442 records), at least one original PMA for 60 (744 records) and at least one De Novo for 26 (53 records); 40 brands matched nothing, mostly because their legal applicant names differ from the brand [2][3][4]. An unmatched brand is a matching limit, and this article draws no conclusion from it.

Read in context, the eight "approved" sites divide cleanly. Five belong to companies with original PMA records, and the wording refers to PMA-class products: leadless pacemakers, implantable defibrillators, cochlear implants, a dermal regeneration template and bone-growth stimulation. Two refer to drug or contrast-agent approvals, where "approved" is the correct word. One applies "approved by US FDA" to an aesthetic device from a company whose matched FDA records are 510(k) clearances only. That is the single apparent mismatch flagged by this bounded crawl. Brand-to-applicant matching alone cannot establish a product-level violation; the exact authorization and current label need review. The example is anonymized [5].

The other reviewed wording families appeared consistent with their described context. The 13 "cleared" sites all describe 510(k) decisions. Both "FDA registered" sites use the term for manufacturing facilities, which is exactly what registration describes. The one "FDA compliant" mention describes a compliance program on a regulatory-services page. One imaging manufacturer's newsroom still carried an unfilled template fragment reading "[510(k) clearance/PMA approval]", a small sign that the person drafting the page was unsure which decision applied [5].

VayoMed's judgment: the sampled corporate pages show limited FDA language and few apparent mismatches. The crawl cannot tell whether those pages passed an internal regulatory review. That silence is a missed opportunity as much as a safety margin. A product page that states the pathway, the identifier and the cleared indication gives buyers and answer engines a verifiable fact; a page that says nothing leaves the definition to the copies discussed next.

Where the wording slips: press releases

Releases were sampled from PR Newswire's news search on 12 September 2026 using six phrases: "510(k)", "De Novo", "premarket approval", "FDA registered", "FDA clearance" and "FDA approved device". The searches returned 716 unique releases dated from late September 2025 to 11 September 2026; 14 market-research promotions were excluded, leaving 702. Each release was assigned to a cohort by the pathway it cites, and its title, subtitle and body were checked for "approved", "cleared", "granted" or "authorized" and "certified" [6].

The clearance headline is disciplined. Among 178 releases that cite a 510(k) and no PMA, De Novo, HDE or EUA, no title said "approved" and 64 said "cleared"; 147 bodies used "cleared". Seven bodies (3.9%) contained "approved" somewhere, and on reading, those mentions referred to trials, drugs, an industry statistic about AI-enabled devices or an earlier decision for a different age group rather than to the cleared device. One release used "approved" with no "cleared" anywhere [6]. The sampled headlines were consistent on this distinction; the reasons for that consistency and the editorial controls behind it remain unmeasured.

The drift starts where the template runs out. Of 57 releases about a De Novo decision, no title said "approved", five said "cleared" and six said "granted" or "authorized". In the bodies, 26 used "granted" or "authorized", 23 used "cleared" and six used "approved"; two of those, from one company, called the De Novo device "the only FDA approved ... device of its kind" [6]. A De Novo grant is the harder decision to describe because the verb is unfamiliar, and the sample shows companies reaching for the nearest familiar word in both directions.

"FDA registered" is the weakest phrase in the sample and the most common. Of 151 releases using it, 142 cited no premarket decision at all. In 104 the term described a facility, laboratory, manufacturer or 503B site, a context compatible with establishment registration but not independently verified for each entity; in 41 the context was unclear; and in six it was attached to a product: "FDA-registered medical devices", an "FDA-registered infrared thermal camera", "FDA-registered anti-gravity mobility technology", an "FDA-registered Class I medical device" and an "FDA-registered system" [6]. Six is a small number in a 702-release sample; these are six product-level registration phrases for review under the regulation's misleading-impression standard, not six adjudicated violations. Many releases in this cohort came from supplement, cosmetic, pet-food and compounding companies, which follow additional category-specific requirements beyond facility registration.

Breakthrough designation releases numbered 45, and six titles paired the designation with a clearance or approval; where the later decision exists, that pairing is accurate. The five EUA releases used "authorized" and none said "approved" [6].

Two conclusions follow. First, the wording risk in wire releases is concentrated in second-tier statuses: De Novo, exempt and registered-only, and the "about the company" boilerplate paragraph where "FDA-registered" tends to live. Second, a wire release is the copy that travels. VayoMed's distribution benchmarks documented how many third-party pages one release produces; syndicated copies can retain the original boilerplate after a newsroom correction unless the publisher or distributor also updates them.

What FDA has actually done about it

The warning-letter index that FDA publishes covers letters posted from January 2021 to 28 July 2026: 3,643 letters across all centers, of which 262 were issued by CDRH or carry a device subject line. Every letter was scanned in full text for status phrases, for 21 CFR 807.39 and 807.97, and for misbranding language, and every candidate was read [8].

Twenty-six device letters quote "approved", "registered", "certified" or "cleared" wording as false or misleading or cite one of the two misbranding sections. Nineteen date from 2021, when they were 29.7% of that year's 64 device letters and were addressed mostly to sellers of masks, COVID-19 tests and sanitizing devices; ten of the 26 carry COVID-19 subject lines. Since then the count has been two in 2023, one in 2024, two in 2025 and two in the first seven months of 2026, with none in 2022. "Approved" appears as a cited claim in 24 of the 26 letters, "registered" in 13, "certified" in four and "cleared" in three; 807.39 is cited in 11 letters and 807.97 in one; CDRH issued 22 [8].

The letters are useful less for their number than for their conditions, which show how FDA reads a page:

• In August 2025 FDA told SeniorLife Technologies that "FDA Approved" appeared on its website and that a statement "FDA Certified" was "both false and misleading because FDA has not 'certified' your device", adding that consumers rely on seller information and the presentation "conveys the misimpression that the products have been reviewed and approved by FDA" [23].
• In June 2023 FDA cited 21 CFR 807.97 to Vitang Technology, whose website said "FDA APPROVED" and carried the FDA logo for a clear aligner system [24].
• In March 2025 FDA noted that DRG Instruments described one product as "Now FDA Approved" while another page called it "FDA exempt for Class I", and asked for clarification because "indicating that a class I 510(k) exempt product has been reviewed and approved by FDA could be misleading" [25].
• In May 2026 FDA cited 21 CFR 807.39 to Skytron for a brochure calling a disinfection system "the first FDA registered UVC device" [26].
• In August 2021 FDA told Pairon Solutions that "FDA Registered" and "Certified: FDA" beside the FDA logo created an impression of approval, and that a legible small-font disclaimer quoting 807.39 on the certificate "does not limit or otherwise mitigate the misleading impression" [27].
• In February 2026 FDA held ExThera Medical responsible for a distributor's webpage that said its blood filter was "FDA cleared" to treat COVID-19 and sepsis when the product held an emergency authorization, describing the statements as false and misleading about regulatory status [28].

Three patterns recur: a status word attached to a product that lacks that decision, a registration number or certificate used as a badge, and a distributor's page counted against the manufacturer. The disclaimer finding matters most for commercial teams, because a footnote is the usual defense.

VayoMed's judgment: these letters establish concrete enforcement examples, but provide no denominator for estimating any company's probability of enforcement. The 2021 concentration also limits extrapolation to ordinary device marketing. The daily cost of loose wording is different. Value-analysis committees and distributors check the FDA databases, and an "approved" claim that resolves to a K number costs credibility at exactly the moment the company is asking to be trusted.

What AI answers repeat

The sampled answers contain status phrases and category-level hedges. The study did not trace each phrase to an upstream source or measure hallucination rates. VayoMed's stored category panels make that visible. For 38 device and service categories, four assistants (ChatGPT, Claude, Gemini and Perplexity) produced 152 answers in June 2026; 33 used an FDA status phrase [5].

"Cleared" led, with 59 mentions across 27 answers. "FDA approved" appeared nine times across seven answers, in categories built on 510(k) devices: remote patient monitoring platforms, patient monitoring systems, digital pathology, sterilization equipment, surgical robots and regulatory consulting. "FDA registered" appeared in three answers, "FDA compliant" in three and "FDA certified" in two; De Novo was mentioned once [5]. The "approved" and "certified" phrases sat in vendor descriptions. This locates the wording within the answer, while its upstream source remains unresolved.

The live probe tested the current Google AI Mode. On 12 September 2026, twelve queries were run twice each from a US desktop profile: five definition queries ("fda cleared vs fda approved", "is 510(k) FDA approved", "fda registered vs fda approved", "is a De Novo device FDA approved", "what does FDA registered mean for a medical device") and seven category questions of the form "are [continuous glucose monitors, pulse oximeters, portable ultrasound machines, surgical robots, remote patient monitoring devices, digital pathology scanners] FDA approved" and "is AI radiology software FDA approved" [7].

All 24 samples returned an answer. Every category sample used "cleared", and nine of the 14 also used "approved", almost always as the hedge "cleared or approved"; one continuous-glucose-monitor answer opened with "regulated and approved (or cleared)". Nine of the 14 included a sentence explaining the difference. None used "certified". The definition answers described 510(k) as clearance, PMA as approval and De Novo as granted authorization, and cited fda.gov in most samples [7]. This is a September 2026 observation of a stochastic system, and two samples per query describe a tendency rather than a ranking.

The distinction is between category and product claims. "Cleared or approved" can accurately describe a category containing both pathways; an exact product question needs an exact authorization. Adjacent research shows that regulatory terminology can influence perceptions, although the experiment below tested "breakthrough" wording about a hypothetical drug, not "approved" wording about a device. In a randomized trial of press-release wording, Krishnamurti and colleagues found that adding "breakthrough" to a facts-only description of a hypothetical drug raised the share of participants rating it "very" or "completely" effective from 11% to 25%, and the share rating the evidence strong from 43% to 63% [29]. Kesselheim and colleagues surveyed 692 physicians about drug approval standards: 73% believed approval meant comparable effectiveness to other approved drugs, 70% believed it required both a statistically significant and a clinically important effect, and 52% believed randomized trials were needed for a breakthrough therapy designation [30]. Those studies concern drugs. A separate survey also found limited self-reported knowledge of device regulation, using a different population and measure. In a 2024 national survey of 509 internists, cardiologists and oncologists, 41% reported moderate or better understanding of FDA's drug approval process and 17% reported the same for device approval, and the authors concluded that physicians assume the supporting evidence is more rigorous than it often is [31].

These studies make precision worth testing, but do not quantify how the sampled AI answers affected device buyers. The manufacturer's lever is the retrievable text: a product page and a release that say "FDA cleared (K number) for [indication]" give the engine a precise phrase to quote instead of a hedge.

The claim-language audit routine

The order of the checks follows the order in which copies are made, because the copy that travels furthest is the one to fix first. Each check is derived from a finding above.

1. Release archive: Read every release from the last 24 months for the words "approved", "registered" and "certified", starting with De Novo announcements and the boilerplate paragraph; correct the newsroom copy and send the corrected text to the wire and to the syndication partners that carry it.
2. Distributor and marketplace pages: Search distributor sites and marketplaces for the product name plus "FDA"; the ExThera letter counted a distributor's page against the manufacturer. Send authorized partners the matrix wording.
3. Certificates and badges: Remove registration certificate images, FDA logos and "FDA registered" or "FDA certified" badges from product pages, brochures and packaging renders; a small-font disclaimer changes nothing in FDA's reading.
4. Site templates and metadata: Search product pages, specification tables, PDFs, meta descriptions and alt text for "FDA approved"; replace with the pathway phrase and add the indication. The crawl found one unfilled "[510(k) clearance/PMA approval]" placeholder in a live newsroom.
5. LinkedIn and decks: Check the company About section, executive bios, investor decks and webinar slides; Breakthrough designation lines should state that authorization is pending or name the later decision.
6. Identifier beside every claim: Publish the K, DEN, P or H number and, for exempt products, the registration number and product code next to the status phrase, so a buyer or an answer engine can verify the record.
7. One owner: Name the regulatory affairs reviewer who signs off status wording in digital assets, releases and partner materials, and keep the matrix as the shared standard.

What this means for the growth engine

Accurate status wording is public evidence, and public evidence is what the rest of a growth engine reuses. VayoMed builds and runs the website, content, LinkedIn, domain, PR and AI-visibility infrastructure that life-sciences companies need to become visible globally, as one Done-for-You annual subscription. Every part of that system publishes the company's regulatory status somewhere: a product page, a source-grounded article, a company update, a monthly release. If the six parts draw on one matrix and one reviewer, the copies agree with each other and with the FDA record; if they draw on six drafts, inconsistent copies become harder to detect; this study did not test that workflow causally.

The AI lane closes the loop. VayoMed's AI Recommends panels and the probe in this article show cited explainers and recurring product-status wording; the causal path from vendor boilerplate to an answer remains unresolved. A company whose retrievable text states "FDA cleared (K number) for [indication]" on the page, in the release and on LinkedIn has given those engines the precise phrase, and the identifier that lets a buyer confirm it. Content in VayoMed's engine follows the client's regulatory review path for exactly this reason: the review is what turns a claim into evidence. Companies commercializing after a clearance, or expanding into new markets with a home-market record, can start with the seven checks above; VayoMed can run them as part of the engine it operates.

Methodology and limits

Lane A used four FDA bulk exports dated 22 July 2026 (510(k) 175,559 records; PMA 56,765; product classification 7,084; registration and listing 419,651 processed rows) and the FDA De Novo database queried on 12 September 2026 (494 grants) [1][2][3][4][12]. Listing pairs are declarations, not products or units; the product-code submission type is the pathway generally required for that code, not the decision behind an individual listing; 510(k) counts are decisions, including repeat clearances for one product line.

Lane B crawled the 188 tracked domains on 12 September 2026 with a browser-identified curl request, 20-second timeouts, one retry and scheme and www fallbacks, reading initial HTML of the home page plus up to three keyword-selected internal pages; status phrases were matched by regular expressions over visible text, meta descriptions and alt text, and brands were matched to FDA applicants by token containment with documented aliases [5]. Deeper archives were not crawled, so the result describes phrase detection in these fetched pages rather than population prevalence; 27 non-English sites reduce recall; an unmatched brand proves nothing.

Lane C scanned the full text of 3,643 warning letters posted from January 2021 to 28 July 2026, flagged device letters by issuing center or subject line, and read every candidate before counting [8]. Counts are letters that quote wording; wording alone is rarely the sole charge, and the index begins in 2021.

Lane D tallied phrases in 152 stored assistant answers generated in June 2026 across 38 device and service categories, and ran 24 Google AI Mode queries on 12 September 2026 (12 queries, two samples each, US desktop) [5][7]. Answers vary between samples and over time.

Lane E collected 716 PR Newswire releases through six keyword searches on 12 September 2026, excluded 14 market-research promotions, and classified the 702 remaining by cited pathway and by wording in title, subtitle and body, with manual reading of every "approved" context in the 510(k) and De Novo cohorts and every product-level "registered" context [6]. One wire and six keywords over about a year; companies that use that wire are over-represented.

Lane F consists of the regulation text, FDA's pathway and consumer pages, six public warning letters and three peer-reviewed studies, each verified on the primary page in September 2026. Search volumes come from Google Ads keyword data for the United States retrieved through DataForSEO [9].

Frequently asked questions

Is a 510(k) clearance an FDA approval?

No. A 510(k) clearance is FDA's determination that a device is substantially equivalent to a legally marketed predicate, and 21 CFR 807.97 states that this determination denotes no official approval and that a representation creating an impression of approval because of it is misleading and constitutes misbranding [10][14]. The accurate phrase is "FDA cleared", with the K number and the cleared indication.

Can we describe our device as "FDA registered"?

Registration describes the establishment, and listing describes the device the establishment has told FDA it handles; neither is a review of the device. 21 CFR 807.39 treats a representation that creates an impression of approval because of registration or a registration number as misbranding, and FDA states that it issues no registration certificates [11][21]. "Our facility is registered with FDA and the device is listed" is accurate; "FDA registered device" is the phrase the warning letters quote.

Does Breakthrough Device designation mean the device is approved?

No. Designation is a review-program status granted before a marketing submission is decided; the device still needs a 510(k) clearance, a De Novo grant or a PMA approval, and FDA generally keeps the designation confidential until then unless the sponsor discloses it [20]. Copy should name the designation and either state that marketing authorization is pending or name the later decision and its identifier.

Sources

1. FDA, Establishment Registration & Device Listing database, export of 22 July 2026; VayoMed analysis, accessed September 2026. 419,651 processed rows, 222,153 distinct establishment and product-code listing pairs, 25,420 establishments; pathway assigned from the product code's required submission type.

2. FDA, 510(k) Premarket Notification database, export of 22 July 2026; VayoMed analysis, accessed September 2026. 175,559 records; substantially equivalent decisions by year; applicant matching for the website audit.

3. FDA, Premarket Approval (PMA) database, export of 22 July 2026; VayoMed analysis, accessed September 2026. 56,765 records, of which 1,471 original PMAs and 55,294 supplements; original approvals by year.

4. FDA, De Novo database (Device Classification Under Section 513(f)(2)), queried 12 September 2026; VayoMed analysis. 494 grants with decision dates from 1998 to 3 September 2026; requester matching for the website audit.

5. VayoMed, AI Visibility Reports, accessed September 2026. The 188-domain tracking cohort crawled on 12 September 2026 for status language, and the stored category answers (four assistants, June 2026) tallied for status wording; VayoMed analysis.

6. PR Newswire, News release search, releases collected 12 September 2026; VayoMed analysis. 716 releases from six keyword searches, 702 analyzed after excluding market-research promotions.

7. VayoMed, Google AI Mode probe via DataForSEO, 12 September 2026 (VayoMed analysis; method described in this article). Twelve queries, two samples each, US English desktop; wording tallies and cited domains.

8. FDA, Warning Letters, index of letters posted January 2021 to 28 July 2026; VayoMed analysis, accessed September 2026. 3,643 letters scanned in full text; 262 device letters; 26 that quote status wording.

9. DataForSEO, Google Ads keyword search volume, United States, retrieved 12 September 2026. Monthly volumes for "fda cleared vs fda approved" and related queries.

10. Legal Information Institute, 21 CFR 807.97 Misbranding by reference to premarket notification, accessed September 2026. Regulation text quoted in this article.

11. Legal Information Institute, 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number, accessed September 2026. Regulation text quoted in this article.

12. FDA, Download Product Code Classification Files, export of 22 July 2026; VayoMed analysis, accessed September 2026. 7,084 product codes and the submission-type legend (510(k), PMA, 510(k) exempt, HDE, enforcement discretion, EUA).

13. Darrow JJ, Avorn J, Kesselheim AS, FDA Regulation and Approval of Medical Devices: 1976-2020, JAMA 2021;326(5):420-432, accessed September 2026. Annual novel PMAs of 8 to 56 and 510(k) clearances of 2,804 to 5,762 from 1987 to 2020.

14. FDA, Device Approvals and Clearances, accessed September 2026. FDA's definitions of 510(k) substantial equivalence and premarket approval.

15. Shah P, et al., The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases, American Journal of Medicine 2023;136(2):172-178, accessed September 2026. Published research existed for 17.8% of 1,000 devices cleared in 2013 and 2014.

16. Legal Information Institute, 21 CFR 860.200 De Novo classification: purpose and applicability, accessed September 2026. De Novo classification into class I or II where no legally marketed predicate exists.

17. FDA, Humanitarian Device Exemption, verified September 13, 2026. HDE probable-benefit standard, exemption from effectiveness requirements and use restrictions.

18. FDA, Class I and Class II Device Exemptions, accessed September 2026. Most class I and some class II devices are exempt from 510(k), subject to limitations, and remain subject to other controls.

19. FDA, Emergency Use Authorization, accessed September 2026. Section 564 authority to authorize unapproved products or unapproved uses during a declared emergency.

20. FDA, Breakthrough Devices Program, accessed September 2026. Program scope, the standard for marketing authorization, confidentiality of designations, and 210 authorizations as of 30 June 2026.

21. FDA, Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?, accessed September 2026. Registration denotes no approval, clearance or authorization; FDA issues no registration certificates.

22. FDA, FDA Requests Firms Stop Issuing Misleading Registration Certificates, bulletin of 3 March 2021, accessed September 2026. CDRH statement on registration certificates and what a listing entry indicates.

23. FDA, Warning letter to SeniorLife Technologies, Inc., 21 August 2025, accessed September 2026. "FDA Approved" and "FDA Certified" website statements.

24. FDA, Warning letter to Vitang Technology LLC, 12 June 2023, accessed September 2026. "FDA APPROVED" website statement; 21 CFR 807.97 cited.

25. FDA, Warning letter to DRG Instruments GmbH, 31 March 2025, accessed September 2026. "Now FDA Approved" beside "FDA exempt for Class I".

26. FDA, Warning letter to Skytron, LLC, 19 May 2026, accessed September 2026. "First FDA registered UVC device"; 21 CFR 807.39 cited.

27. FDA, Warning letter to Pairon Solutions LLC, 9 August 2021, accessed September 2026. "FDA Registered" and "Certified: FDA" with the FDA logo; small-font disclaimer finding.

28. FDA, Warning letter to ExThera Medical Corporation, 6 February 2026, accessed September 2026. Distributor webpage stating the device was "FDA cleared" for COVID-19 and sepsis.

29. Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B, A Randomized Trial Testing US Food and Drug Administration "Breakthrough" Language, JAMA Internal Medicine 2015;175(11):1856-1858, accessed September 2026. "Breakthrough" wording raised perceived effectiveness from 11% to 25% and perceived evidence strength from 43% to 63%.

30. Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM, Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation, JAMA 2016;315(14):1516-1518, accessed September 2026. 692 respondents; 73%, 70% and 52% figures.

31. Dhruva SS, Kesselheim AS, Woloshin S, Ji RZ, Lu Z, Darrow JJ, Redberg RF, Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey, Health Affairs 2024;43(1), accessed September 2026. 509 physicians; 41% for drug approval and 17% for device approval reported moderate or better understanding.