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.
Graft, Vascular, Synthetic/Biologic Composite
Cardiovascular
The synthetic/biologic composite vascular graft is a cardiovascular implant used to replace or bypass diseased blood vessels, combining synthetic polymer materials with biological components to improve biocompatibility and patency. It is classified as FDA Class II under 21 CFR 870.3450, requiring 510(k) premarket clearance within the Cardiovascular specialty. The product code is MAL and the implant flag is set, reflecting its permanent or long-term surgical placement within the vascular system. Full GMP quality system requirements apply.
510(k) Clearances
6 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.