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.
Non-Factor Replacement Product Test System
Hematology
A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products (used for routine prophylaxis in patients with bleeding disorders including hemophilia) in human blood specimens, ensuring that therapeutic drug levels are within the range specified in the approved product labeling for appropriate management. It is classified as FDA Class II (510(k) required) under regulation 864.7298 in the Hematology specialty, with product code SES. The device is not an implant and does not support life-sustaining functions.
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.