Regulatory pathway · all topics

Predicate Device Selection for 510(k)

A predicate device must be legally marketed in the US, not subject to PMA, and not removed from the market for safety or effectiveness reasons. Substantial equivalence requires same intended use AND either same technological characteristics or different characteristics that do not raise different questions of safety/effectiveness. Reference devices may be used to support a single SE comparison if combined with a primary predicate. Multiple predicates must each be addressed individually. FDA's '510(k) Submissions Database' is the authoritative search tool.

Source

FDA, 'The 510(k) Program: Evaluating Substantial Equivalence' (July 2014)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k

How MedTek OS handles this

Compass drafts the predicate device selection for 510(k) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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