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.
Hemostatic Wound Dressing With Thrombin Or Other Biologics
Unknown
The Hemostatic Wound Dressing with Thrombin or Other Biologics is a wound dressing incorporating biologic agents such as thrombin to temporarily control bleeding and cover external wounds by promoting clot formation at the wound site. Its classification is currently unclassified (pending formal classification determination), reviewed under the General and Plastic Surgery panel. Because it contains biologic components that affect classification boundaries, a formal regulatory pathway has not yet been assigned. It is not an implant and not life-sustaining.
510(k) Clearances
18 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.