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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Penile Implant Surgical Accessories
Gastroenterology, Urology
The Penile Implant Surgical Accessories are a set of manual devices designed for surgical procedures associated with the implantation of penile inflatable or penile rigidity implants, including cylinder sizers, insertion tools, placement tools, connector assembly tools, corporeal dilators, tubing passers, measurement tools, and hemostats. They are classified as FDA Class 1, with no premarket notification required, under regulation 876.3500 in the Gastroenterology and Urology specialty. The product code is QGA. These accessories are not themselves implants.
No 510(k) clearances found for "QGA". Try a different K-number, product code, or device name.
What 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.