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.
Washer, Cleaner, Automated, Endoscope
Gastroenterology, Urology
The Automated Endoscope Washer/Cleaner is a device intended to clean endoscopes through an automated process that includes a chemical dispensing system metering predetermined volumes of detergent during cleaning cycles, with each lumen end positioned in a tray to allow detergent and rinse water to pass through. Endoscopes must be pre-cleaned and leak-tested prior to processing. It is an FDA Class 2 device regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, reviewed by the General Hospital panel, with product code NVE, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
12 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.