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.
Endoscope, Accessories, Narrow Band Spectrum
Gastroenterology, Urology
The Narrow Band Spectrum Endoscope Accessories device provides an alternative mode of endoscopic visualization using narrow spectral bands of visible light for illumination, enhancing contrast of mucosal surfaces during endoscopy and endoscopic surgery of the upper and lower digestive tract and urinary tract. This technology improves detection of vascular patterns and superficial mucosal lesions. It is an FDA Class 2 device regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, with product code NWB, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
9 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.