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.
Test, Erythrocyte Sedimentation Rate
Hematology
The Test, Erythrocyte Sedimentation Rate is a hematology diagnostic device used to measure the rate at which red blood cells settle in a vertical column of anticoagulated blood over one hour, a nonspecific marker of systemic inflammation used to screen for and monitor inflammatory, infectious, and neoplastic conditions. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. It carries product code JPH and is regulated under 21 CFR 864.6700, within the Hematology medical specialty.
510(k) Clearances
7 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.