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
Venous Window Needle Guide
Gastroenterology, Urology
The Venous Window Needle Guide is a gastrointestinal and urology device used as an access accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site (buttonhole) cannulation technique, guiding needle insertion to the same location at each treatment session to maintain fistula integrity. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5540, requiring 510(k) premarket notification. It is flagged as both an implant and life-sustaining, reflecting its role in maintaining vascular access for patients dependent on hemodialysis.
510(k) Clearances
1 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.