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, Femoral
Gastroenterology, Urology
A femoral catheter is a vascular access device inserted via the femoral vein or artery and used for hemodialysis, hemodynamic monitoring, or the administration of fluids and medications in critically ill or renally impaired patients. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LFK and is regulated under 21 CFR 876.5540 within the Gastroenterology and Urology specialty. This device is flagged as both an implant and a life-sustaining or life-supporting device, reflecting its critical role in patient care.
510(k) Clearances
16 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.