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.
Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Gastroenterology, Urology
The Non-Implanted Peripheral Nerve Stimulator for Urinary Incontinence is a device that delivers electrical stimulation to peripheral nerves, such as the posterior tibial nerve, through external electrodes to modulate bladder function and reduce symptoms of urinary incontinence. It is used as a non-surgical neuromodulation therapy. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 876.5310 (Gastroenterology and Urology specialty).
510(k) Clearances
8 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.