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, Image Post-Processing For Color Enhancement
Gastroenterology, Urology
The Endoscope Image Post-Processing Accessory for Color Enhancement is a gastrointestinal device that provides an alternative mode of visualization using image post-processing algorithms applied to received white-light endoscopy images for color enhancement, improving mucosal visibility without using additional light sources. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.1500, requiring 510(k) premarket notification. This technology helps endoscopists identify subtle mucosal lesions or vascular patterns that may be less visible under standard white-light imaging. It is not an implant and is not life-sustaining.
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.