Predicate

A legally marketed medical device used as a baseline comparison for a new device submission.

A predicate refers to an existing cleared or approved device used in 510(k) notifications to establish substantial equivalence. What the FDA reviews is that comparison to determine if the new device raises new safety questions.

Explore the data behind the terms

HaRi brings the FDA, MHRA, EUDAMED, Health Canada and TGA registers into one search: devices, manufacturers, product codes and safety events, all cross-referenced and free to explore.

Search HaRi→