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.
Device, Incontinence, Urosheath Type, Sterile
Gastroenterology, Urology
The sterile urosheath-type incontinence device is an external condom catheter or penile sheath system designed to collect urine in male patients with urinary incontinence, connecting to a drainage bag via tubing. It is classified as FDA Class 1, indicating minimal risk, requiring only general controls. The product code is EXJ, regulated under 21 CFR 876.5250 in the Gastroenterology, Urology specialty. No special regulatory flags apply.
510(k) Clearances
22 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.