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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: KKX FDA class 2

    Drape, Surgical

    General, Plastic Surgery

    View full classification →

    A Surgical Drape is a sterile barrier device used during surgical procedures to create and maintain an aseptic field around the operative site, reducing the risk of microbial contamination and surgical site infection. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is KKX, the regulation is 21 CFR 878.4370, and the medical specialty is General and Plastic Surgery. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BeneHold™ Surgical Incise Drape with CHG antimicrobial II
    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
    BeneHold Surgical Incise Drape with CHG antimicrobial
    ControlRad Sterile Cover
    MediClear PreOp
    Plus Surgical Drapes (EO Sterilized), PMDB-XXX
    HONGYU DISPOSABLE SURGICAL DRAPES
    SURGICAL DRAPE
    3M STERI-DRAPE FABRIC SURGICAL DRAPES
    WHITNEY MEDICAL SOLUTIONS ESHIELD
    3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
    SURGISLEEVE WOUND PROTECTOR
    AVD RIGHT RADIAL DRAPE
    TIBURON SURGICAL DRAPE
    DAS MEDICAL EQUIPMENT DRAPES
    SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
    HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
    COBES SURGICAL DRAPE
    GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
    TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
    SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
    RADSCAN EQUIPMENT SLICKER
    NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H
    KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
    IMC SURGICAL DRAPE
    EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
    EMM EQUIPMENT COVER-POLYTHYLENE
    EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
    BUSSE SURGICAL DRAPES IV
    IMC SURGICAL DRAPE
    BUSSE SURGICAL DRAPES III
    MRI NEURO DRAPE
    KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
    DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
    BUSSE SURGICAL DRAPE
    BUSSE SURGICAL DRAPE
    SRI LP DRAPE
    PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
    SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
    ENDODRAPE(TM)
    ARROW INTERNATIONAL, INC., SURGICAL DRAPES
    GENERAL SURGERY DRAPES
    ENDODRAPE
    JOYKEY SURGICAL DRAPES (STERILE)
    SURGICAL DRAPES
    TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
    OR SPECIFIC BIG CASE BACK TABLE COVER
    MICROTEK MEDICAL WARMING DRAPE
    EQUIPMENT SLUSH DRAPE
    GORE-TEX NON-STERILE SURGICAL GOWNS

    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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