Preamendments device

Preamendments devices can serve as predicates in a 510(k). Class III device types for which FDA has not yet required PMAs can still reach the market through a 510(k) on that basis.

A device commercially distributed in the United States prior to May 28, 1976 that has not been significantly changed or modified since then, and for which premarket approval has not been required under section 515(b) of the FD&C Act.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology