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.
Pericardial Patch To Facilitate Revision Surgeries
Cardiovascular
The Pericardial Patch To Facilitate Revision Surgeries (product code OMH) is a Class 2 implantable cardiovascular device regulated under 21 CFR 870.3470 in the Cardiovascular specialty (CV), cleared via 510(k). It serves as a pericardial patch or pledget whose secondary function is to facilitate revision cardiac surgeries by providing a dissection plane, and is distinct from devices primarily intended to minimize adhesion formation. The device is flagged as both an implant and life-sustaining or life-supporting, reflecting its use in high-stakes cardiac surgery.
510(k) Clearances
1 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.