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    Tool · 510(k)

    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.

    Product Code: KFF FDA class 2

    Assay, Heparin

    Hematology

    View full classification →

    Heparin Assay is an in vitro diagnostic device used to measure heparin concentration in patient blood samples, enabling monitoring of anticoagulation therapy in patients receiving heparin for the prevention or treatment of thrombosis and related conditions. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KFF, regulated under 21 CFR 864.7525, within the Hematology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    46 matches
    K Number
    Device Name
    HemosIL Liquid Anti-Xa
    INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
    STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
    HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
    BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
    ENOXAPARIN TEST CARD
    ACTICHROME HEPARIN (ANTI-FIIA)
    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
    HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
    COAMATIC HEPARIN
    IL TEST HEPARIN
    SPECTROLYSE HEPARIN (ANTI-IIA)
    MDA HEPARIN ANTI-X ASSAY
    CHROM Z-HEPARIN, CAT. NO 5242
    COACUTE HEPARIN
    HBPM/LMWH CONTROL KIT
    HEPARIN CONTROL KIT
    THE HEPANORM HBPM/LMWH KIT
    ROTACHROM HBPM/LMWH TEST KIT
    ROTACHROM HEPARIN TEST KIT
    THE STACHROM HEPARIN ASSAY KIT
    STACLOT HEPARIN TEST KIT
    HEPARIN MANAGEMENT TEST CARD; HMT CARD
    HEMOLAB HEPARICHROM ASSAY
    IL TEST HEPARIN (XA), PN 84699-15
    SPECTROLYSE HEPARIN KIT
    BERICHROM HEPARIN
    HITT BY HEMOCHRON(R)
    HEPARIN CONTROLS, HIGH AND LOW
    HEMOCHRON(R) HEPARIN RESPONSE TEST
    ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
    COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
    ORTHOKROME* HEPARIN
    HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
    IL TEST 97575-15, HEPARIN ASSAY
    HEPANORM CALIBRATION PLASMA SET
    HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
    GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
    HEPARIN CALIBRATOR ACA
    HEPARIN ACA ANALYTICAL TEST PACK
    HEPARINOMETER
    COATEST HEPARIN
    DIACROM * HEPARIN
    CI-TROL HEPARIN CONTROLS, LOW/HIGH
    HEPARIN ASSAY

    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.

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