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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.

    Let the assistant find your predicates

    Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples
    Product Code: NAD FDA class 1

    Dressing, Wound, Occlusive

    General, Plastic Surgery

    View full classification →

    The Occlusive Wound Dressing is a wound care product that creates an airtight or near-airtight barrier over a wound, preventing moisture evaporation and protecting against external contaminants while maintaining a moist healing environment conducive to tissue repair. Classified as FDA Class 1, it is subject to general controls under regulation 878.4020 (General and Plastic Surgery specialty).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
    APLION TOPICAL CARE SYSTEM
    ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
    CENTURION SORBAVIEW OTC
    DERMASTREAM
    OXYBAND WOUND DRESSING
    WET CHAMBER
    KERLIX MD ANTIMICROBIAL GAUZE DRESSING
    WOUND DRESSING/ABD PAD, MODEL #10810
    OTOSILK OTOLOGICAL GRAFT DRESSING
    DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
    ALLDRESS MULTI LAYERED WOUND DRESSING
    OTOSILK
    MEDLINE STERILE GAUZE SPONGES
    FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
    MONTROSE DRESSING APPLICATORS
    MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
    TENSOPLUS LITE
    HYDRASORB(TM)
    SORBEX(TM) SOFT SPONGE
    HERMAL WOUND CARE KIT
    2018 ARTERIAL/VENOUS PRESSURE DRESSING
    HYPAFIX DRESSING RETENTION SHEET
    STERIL-DERM TRANSPARENT WOUND DRESSING
    BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52
    STERILE BURNNET PRE-CUT (VARIOUS SIZES)
    AREOLA/NIPPLE DRESSING
    BEAM TECH WOUND DRESSING*
    DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
    PERME-AID TRANSPARENT DRESSING, #11XX
    DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
    TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
    MODIFIED LABELING FOR POLYDERM WBC(TM)
    FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
    POLYMER ADHESIVE BANDAGE
    ALLEVYN TRACHEOSTOMY DRESSING
    REPLICARE (ADDITIONAL CLAIMS)
    TECNOL VARIABLE TENSION BANDAGE
    PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
    AD-HEAL(TM) WOUND DRESSING
    OPER-FILM-ADHESIVE MEMBRANE
    DERMICEL, MONTGOMERY STRAP
    3M WOUND CONTACT MATERIAL, PRODUCT #563X
    POLYDERM A+B(TM)
    BFGOODRICH BIOTHANE NON-ADHERENT DRESSING
    DUODERM(R) CGF
    POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
    ENVICLUSIVE (TM)
    PHARMACLUSIVE (TM)
    MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)

    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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