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.
Implanted Tibial Electrical Urinary Continence Device
Gastroenterology, Urology
The implanted tibial electrical urinary continence device (product code QXM) is a Class 2 implantable prescription device in the Gastroenterology/Urology specialty (regulation 876.5305) that receives power from a non-implanted external power source to deliver electrical stimulation to the tibial nerve near the ankle. It is indicated for the treatment of overactive bladder-related symptoms including urge urinary incontinence, urinary urgency, urinary frequency, and nocturia, and requires 510(k) clearance. It is classified as an implant but is not 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.