Primary predicate device

When several predicates are cited, FDA expects one to be named as primary. The others can support specific parts of the comparison, but each still has to meet the predicate requirements.

A predicate device with indications for use and technological characteristics that are most similar to the new device. The primary predicate should be identified within a 510(k) submission.

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