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.
Esophageal, Mucosal, Electrical Characterization
Gastroenterology, Urology
The Esophageal Mucosal Electrical Characterization device, also known as the esophageal tissue characterization system, is intended for obtaining measurements of electrical properties within esophageal tissue to aid in diagnostic assessment of the esophageal mucosa. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 876.1450 within the Gastroenterology and Urology medical specialty. The product code is QIS. The device is not an implant and is not flagged as life-sustaining.
510(k) Clearances
3 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.