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.
Hematoxylin
Hematology
Hematoxylin is a naturally derived histological staining reagent used as the principal nuclear dye in the widely employed hematoxylin and eosin (H&E) stain, binding to nucleic acids and imparting a blue-purple color to cell nuclei in tissue sections for diagnostic pathology. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYJ falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
510(k) Clearances
14 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.