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.
Accessories, A-V Shunt
Gastroenterology, Urology
Arteriovenous Shunt Accessories are components used in conjunction with implanted AV shunts in patients undergoing hemodialysis, including clamps, cannulas, and connection fittings that support the maintenance and use of the vascular access device. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNZ and the applicable regulation is 21 CFR 876.5540 in the Gastroenterology and Urology specialty. This device is an implant.
510(k) Clearances
10 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.