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.
Single Needle (Co-Axial Flow) Dialysis Kit
Gastroenterology, Urology
The Single Needle (Co-Axial Flow) Dialysis Kit is a convenience kit used in hemodialysis where a single needle provides both blood withdrawal and return via a coaxial flow design, bundled with associated supplies. It falls under FDA Class 2 in the Gastroenterology and Urology specialty, regulated under 21 CFR 876.5820. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PPL; not an implant and not life-sustaining.
No 510(k) clearances found for "PPL". 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.