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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
    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
    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
    STATSEAL DISC
    QUIKCLOT HEMOSTATIC DRESSING
    INTERVENTIONAL HEMOSTATIC BANDAGE
    NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
    GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
    SOFTSEAL-C
    CELOX GAUZE PRO
    POSISEP AND POSISEP X HEMOSTAT DRESSINGS
    SUNTOUCH TOPICAL HEMOSTATIC DRESSING
    HEMCON HEMOSTATIC GEL
    ADVANCED TRAUMA DRESSING (ATD)
    CLO-SURPLUS P.A.D.
    CORELEADER HEMO-PAD MODEL CPII 02030
    GUARDACARE
    CHITOGAUZE FUSION

    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.

    Popular Product Codes

    Commonly searched
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