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
Drug-Eluting Sinus Stent
Unknown
The Drug-Eluting Sinus Stent is a device designed to mechanically maintain patency following ethmoid sinus surgery while also eluting drugs to reduce the need for post-operative interventions such as surgical adhesion lysis or use of oral steroids. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to its high-risk combination of mechanical and drug-delivery functions. The product code is OWO, with an implant flag indicating it is placed within the body; it is reviewed under the ear, nose, and throat (ENT) panel.
No 510(k) clearances found for "OWO". 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.