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.
Flow Cytometric Reagents And Accessories.
Hematology
The Flow Cytometric Reagents and Accessories device encompasses reagents and accessories used to identify and classify cells or other particles in suspension by their physical properties or associated fluorescent molecules, providing information about the distribution, number, or protein expression of cells in suspension, aiding in the diagnosis of conditions such as immunodeficiency and cancer. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OYE, with regulation number 864.5220 under the Hematology medical specialty.
510(k) Clearances
8 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.