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.
Agent, Absorbable Hemostatic, Collagen Based
General, Plastic Surgery
Agent, Absorbable Hemostatic, Collagen Based is a collagen-derived hemostatic agent applied during surgical procedures to control bleeding from wound surfaces; it works by providing a scaffold that promotes platelet adhesion and aggregation, and is absorbed by the body over time. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA), and is regulated under 21 CFR 878.4490 within the General/Plastic Surgery specialty. The product code is LMF. This device is an implant.
No 510(k) clearances found for "LMF". 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.