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.
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Gastroenterology, Urology
A Reagent Test Strip for Disinfectant Residuals in Dialysate is a chemical test device used to detect and measure residual concentrations of dialysis disinfectants in dialysate fluid before treatment, ensuring patient safety by confirming disinfectant has been adequately rinsed from the dialysis system. It is FDA Class 2 with 510(k) requirements, product code MSY under 21 CFR 876.5665 in the Gastroenterology and Urology specialty, and carries a life-sustaining designation. The device is not an implant.
510(k) Clearances
13 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.