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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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11-Dehydro Thromboxane B2 Kit, Urinary
Hematology
The Urinary 11-Dehydro Thromboxane B2 (11dHTXB2) Kit (product code OBW) is a hematology in vitro diagnostic device that uses an enzyme-linked immunoassay (ELISA) to determine levels of 11-dehydro thromboxane B2 in human urine, aiding in the qualitative detection of aspirin effect in apparently healthy individuals following aspirin ingestion. It is intended for professional laboratory use only and helps assess platelet inhibition by aspirin therapy. This device is FDA Class 2 under regulation 864.5700 in the Hematology specialty, requiring 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
510(k) Clearances
1 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.