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.
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Gastroenterology, Urology
The Triple Lumen Hemodialysis Catheter (Non-Implanted) is a short-term (less than 30 days) central venous access device used for hemodialysis and apheresis, with a third lumen available for infusion of medications or fluids. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIE and regulation 21 CFR 876.5540 in the Gastroenterology and Urology specialty. The device is flagged as life-sustaining/life-supporting due to its role in hemodialysis, and is not an implanted device given its short-term use.
510(k) Clearances
12 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.