Predicate device

Choosing the predicate shapes the whole 510(k), because its intended use and technology set the comparison and the testing needed. A predicate with known safety problems can make the review harder, so its history is worth checking before choosing it.

A legally marketed device (as defined in 21 CFR 807.92(a)(3)) to which a new device may be compared for a determination regarding substantial equivalence because the devices have the same intended use and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness.

FDA guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 2014), Appendix D, Glossary of Significant Terminology