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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: QSY FDA unclassified

    Hemostatic Wound Dressing Without Thrombin Or Other Biologics

    Unknown

    View full classification →

    The Hemostatic Wound Dressing Without Thrombin or Other Biologics is a wound dressing intended to temporarily control bleeding and provide coverage for external wounds using hemostatic mechanisms that do not involve biologic additives such as thrombin. Its classification is currently unclassified (pending formal classification determination), reviewed under the General and Plastic Surgery panel. The distinction from biologic-containing dressings influences its regulatory pathway. It is not an implant and not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BloodSTOP iX Trauma Matrix (TM-iX-20)
    Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm
    MFUSE (MS001)
    TRAUMAGEL® 2.0 Hemostatic Gel
    TRAUMAGEL®
    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
    Hemoblock_S (Prescription); Hemoblock_S (OTC)
    RESPONDER® Polysaccharide Hemostat
    RESPONDER Polysaccharide Hemostat
    Celox Rapid X-Ray Gauze
    Hemostatic Dressing
    Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
    Zeolite Hemostatic Cotton
    Axiostat Gauze
    S.E.A.L. Hemostatic Wound Spray
    Vascette HP (hemostatic pad)
    Zeolite Hemostatic Gauze
    Axiostat Patch
    Hemostatic Xerogel Sponge
    OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
    NasalCEASE and BleedCEASE
    gel-e Flex+ gel OTC
    gel-e Flex+
    QuikClot Radial
    IHM Technology Bandage
    gel-e Flex
    StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
    Axiostat Chitosan Hemostatic Dressing
    Bondiloxs Topical Hemostatic Granules
    InnoSEAL Hemostatic Pad
    WoundClot9
    BloodSTOP iX Battle Matrix
    Nustat XR
    Prometheus ChitoGauze XR PRO
    HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
    AnsCare ChitoClot Pad
    HEMO-Bandage
    Hemogrip Patch
    AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
    NUSTAT, NUSTAT XR
    WOUNDCLOT HEMOSTATIC GAUZE
    STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
    D2 HEMOSTANTIC DRESSING
    BONDILOXS TOPICAL HEMOSTATIC DRESSING
    CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
    PERCLOT TOPICAL
    STATSEAL DISC
    QUIKCLOT HEMOSTATIC DRESSING
    INTERVENTIONAL HEMOSTATIC BANDAGE
    NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING

    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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