WEBVTT

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Is your 510(k) device FDA approved?

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No.

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It's FDA cleared,

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and buyers who check will
notice the difference.

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From 2015 to 2025,

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FDA recorded about 33,000
510(k) clearances,

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343 De Novo grants,

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and only 386 original approvals.

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Approval is about one
decision in a hundred.

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So match each claim to its pathway.

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A 510(k) device is cleared.

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A De Novo device is granted.

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Only a PMA device is approved.

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And registration is not approval either.

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Of 151 press releases that used
the phrase FDA registered,

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142 cited no premarket decision at all.

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Three fixes.

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One: print the K,

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De Novo or PMA number beside every claim.

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Two: correct press releases
and distributor pages first.

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Three: let regulatory affairs
sign off every status phrase.

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Say exactly what FDA decided.

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Nothing more.