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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: KGX FDA class 1

    Tape And Bandage, Adhesive

    General Hospital

    View full classification →

    Adhesive Tape and Bandage is a wound care and dressing product consisting of an absorbent pad or fabric strip coated with a pressure-sensitive adhesive, used in general hospital settings to secure dressings, support bandages, or protect minor wounds during healing. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGX, regulated under 21 CFR 880.5240, within the General Hospital medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SERAGARD INJECTION PATCH
    CARE BAND ANTIBACTERIAL BANDAGES
    SYVEK PATCH
    ADHESIVE BANDAGES WITH OTC DRUG
    TARGETT PATCH
    PARALLEL
    DERMIVIEW HYPOALLERGENIC CLEAR TAPE
    STERILE PLASTIC DRESSING
    BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP
    BAND-AID(TM) BRAND ADHESIVE BANDAGE
    SHIPPERT PRESSURE BANDAGE
    EMPI TAPE PATCHES
    DERMIVIEW CLEAR TAPE
    COVERLET ADHESIVE DRESSING
    KIT PAK DRESSING CHANGE TRAY
    SURGICAL ADHESIVE TAPE
    ACE SPORTS TAPE
    CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
    SPYROGEL WOUND DRESSING
    EPISEAL ADHESIVE WOUND CLOSURE STRIPS
    MEDIMAC BANDAGE
    3M TEGADERM HP TRANSPARENT DRESSING
    MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
    TISSUE ISOLATION AND RETRIEVAL BAG
    I.V. START KIT (AHC-50-54954
    SURESEAL BANDAGE
    ADHESIVE BANDAGES
    TRANSPARENT ADHESIVE DRESSING
    SHAWNEE PRODUCT KIT IV
    BIOCLUSIVE MVP TRANSPARENT DRESSING
    ISOPORE(TM) TAPE, MODIFICATION
    INGROWN TOENAIL PAD
    MEDICOTEST SKIN FIX
    SHAWNEE PRODUCTS KIT II
    LC STRIP
    2ND SKIN STERILE ADHESIVE STRIP
    DERMCO A-I
    STRAPPAL
    ISOPORE TAPE
    LUEKOFLEX SURGICAL TAPE
    DEROYAL EYE DRESSING
    DUODERM SUSTAINED COMPRESSION BANDAGE
    ACRYLASTIC
    TRICOPLAST
    TTL MEDICATED DRESSING
    STRETCH WRAP
    PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
    MARION WINDOW
    SURGICAL MICROPOROUS TAPE (MICROCEL)
    SURGICAL CLOTH TAPE (HEALRITE)

    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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