Multiple predicate devices

Each predicate must share the new device's intended use, and differences in technology must not raise different questions of safety and effectiveness. Combining features from several predicates into a device that none of them resembles, sometimes called a split predicate, is not acceptable.

Two or more predicate devices that have been provided to support an SE determination. If using multiple predicate devices to demonstrate substantial equivalence, each predicate device must have the same intended use as the new device, and any different technological characteristics between the new device and the predicate devices must 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