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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: GFO FDA class 2

    Activated Partial Thromboplastin

    Hematology

    View full classification →

    Activated Partial Thromboplastin (product code GFO) is a hematology reagent used in the activated partial thromboplastin time (aPTT) test, a coagulation assay that evaluates the intrinsic and common coagulation pathways to detect clotting factor deficiencies and monitor anticoagulant therapy. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7925 in the Hematology specialty (HE), it is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Cryocheck Hex LA
    HemosIL Silica Clotting Time
    STA-CEPHASCREEN KIT
    HEMOSIL SYNTHASIL
    HEMOSIL SILICA CLOTTING TIME
    VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
    CARESIDE APTT
    HEMOCHRON JR. CITRATE APTT CUVETTE
    SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
    SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
    HEMOCHRON CITRATE APTT
    IL TEST APTT-SP
    SPECKTIN-LA TEST SET
    SYNTHAFAX APTT REAGENT
    PATHROMTIN SL
    SYNTHASIL APTT REAGENT
    APTT-ES
    APTT-ES REAGENT
    PATHROMTIN
    ACS APCT REAGENT, MODIFIED
    HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
    HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
    STACLOT LA TEST KIT
    PLATELIN L
    ACS FREEZE-DRIED APTT REAGENT
    ACS APCT REAGENT
    ELLAGIC ACID APTT REAGENT
    HEMOCHRON ONESTEP APTT TEST
    HEMOCHRON(R) APTT, MODIFICATION
    ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
    THE THERATEST ACA TEST
    APTT REAGENT
    ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
    APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
    ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
    APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
    APTT BY HEMOCHRON(R)
    COAG-1 APTT TEST CARD
    EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
    THROMBOSCREEN APTT REAGENT
    EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
    BIOTRACK APTT REAGENT CARTRIDGE
    APTT REAGENT
    EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
    KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
    UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
    CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
    ALUMINA SILICA-ACTIVATED PARTIAL THROM
    PLASMA COAGULATION CONT., ABNORMAL
    HEPARIN CONTROL PLASMA

    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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