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.
Absorbable Collagen Hemostatic Agent With Thrombin
General, Plastic Surgery
The Absorbable Collagen Hemostatic Agent With Thrombin (product code PMX) is a Class 3 general and plastic surgery device intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical, regulated under 878.4490. Class 3 classification requires Premarket Approval (PMA). The device is flagged as an implant and is intended for internal use to aid surgical hemostasis.
No 510(k) clearances found for "PMX". Try a different K-number, product code, or device name.
What 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.