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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
Unknown
The Whole Blood Pre-Treatment T-Cell Enrichment Reagent (product code ORL) is a reagent used for the pre-treatment of whole blood prior to lymphocyte separation, aiding in the removal of selected white blood cells from whole blood stored at room temperature. It is used as a preparatory step in immunological assays and cell separation procedures. This device is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA) to demonstrate safety and effectiveness, with no specific regulation number assigned. The medical specialty is not formally designated, and the device is reviewed by the Microbiology panel. It is not an implant and is not life-sustaining.
No 510(k) clearances found for "ORL". 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.