Predicate Device
Also called: predicate
A legally marketed device that a new 510(k) submission claims substantial equivalence to.
Every 510(k) submission names a predicate. The argument is that the new device has the same intended use and either the same technological characteristics or different ones that raise no new questions of safety and effectiveness.
The predicate ecosystem is why medical AI cleared quickly once the first devices in each category existed. The hard regulatory work of category creation only has to happen once.
Where This Gets Misread
Predicate chains are the structural weakness critics point at. A device can be cleared against a predicate that was itself cleared against an earlier one, with each step small and no step requiring fresh clinical evidence. The cumulative distance from the originally validated device can be considerable.