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What is a traditional 510 k?

Introduction. A 510 (k) is a document containing information required under 21 CFR 807 Subpart E. All 510 (k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510 (k)s provide a comparison between the device to be marketed and the predicate device or devices.

What is a 510k number?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval. Learn more...


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