Predicate Device
A legally marketed medical device to which a new device is compared in a 510(k) submission to establish substantial equivalence. The predicate device must have the same intended use and similar technological characteristics.
In the FDA 510(k) pathway, the predicate device is the legally marketed device that the applicant claims their new device is substantially equivalent to. The predicate must be a device that was legally marketed before May 28, 1976, or one that has received 510(k) clearance.
Choosing a predicate
Selecting the right predicate is a strategic decision. The predicate should have the same intended use and similar technological characteristics. Using a predicate with broad Indications for Use can provide more flexibility; using one with narrow indications may simplify the equivalence argument but limit future claims.