510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Aortic Annuloplasty Ring
Cardiovascular
The Aortic Annuloplasty Ring is an implantable cardiovascular device used to correct annular dilatation and/or maintain annular geometry of the aortic valve, typically implanted during aortic valve repair surgery to restore or preserve normal valve function. It is classified as FDA Class 2 under 21 CFR 870.3800 in the Cardiovascular specialty, requiring 510(k) premarket notification. Product code PST; flagged as both an implant and life-sustaining, reflecting its critical role in cardiac function.
510(k) Clearances
2 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.