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.
Prosthesis, Tracheal, Preformed/Molded
General, Plastic Surgery
The Preformed/Molded Tracheal Prosthesis is a surgically implanted airway device intended to provide structural support to weakened or constricting airway walls, maintaining tracheal patency in patients with tracheal abnormalities. It is an FDA Class 2 implant regulated under 21 CFR 878.3720 in the General and Plastic Surgery specialty, reviewed by the Anesthesiology panel, with product code NWA, requiring 510(k) clearance. The implant flag is set reflecting its surgical placement within the trachea. It does not carry life-sustaining support designation.
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.