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.
Orange Ii
Hematology
Orange II is a synthetic monoazo dye used as a histological staining reagent in hematology laboratories for the staining and differentiation of tissue components and eosinophilic structures in microscopic preparations. It is classified as FDA Class 1, indicating low risk subject to general controls only, with no requirement for premarket clearance. The product code is KKE and the applicable regulation is 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.
No 510(k) clearances found for "KKE". 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.