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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: GAD FDA class 1

    Retractor

    General, Plastic Surgery

    View full classification →

    The Retractor (product code GAD) is a surgical instrument used to hold back tissue, organs, or wound edges to maintain clear visualization and access to the operative field during general and plastic surgery procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification requirement. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    JRP Wound Spreader
    OTELO LL
    THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
    DASH
    APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
    QUADRANT RETRACTOR SYSTEM
    MRI FASTSYSTEM RETRACTOR SYSTEM
    CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
    SCION SAPHENOUS VEIN HARVESTING SYSTEM
    VILLALTA RETRACTOR
    RETRACTOR
    RETRACTOR
    LUNG RETRACTORS: DAVIDSON, SEMB
    THOROCOSCOPY SELF-RETAINING RETRACTOR
    HARGIS RECTAL SELF RETRATION SYSTEM
    HARGIS SR2 SELF-RETRACTION SYSTEM
    HARGIS SELF RETRACTION SYSTEM
    ADEPT INSTRUMENT POSITIONING ACCESSORY
    ADEPT ENDOSCOPIC POSITIONER
    LEVY ARTICULATING RETRACTOR
    AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
    REDDICK RETRACTOR
    SUREBREATH DOME, E-Z BREATHER
    TEKDYNE MICRO RETRACTOR
    SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
    GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)
    GOOTT BALFOUR BLADE
    ROBOTRAC (TM) RETRACTOR ARM
    ROLLET RETRACTOR
    KIRSCHNER RETRACTOR
    LOCKING WIRE GUIDE STYLET
    SURGICAL WIRE CUTTERS
    SURGICAL RETRACTORS
    SURGICAL RETRACTORS
    SUREBREATH DOME
    SELF-RETAINING SOFT TISSUE RETRACTOR
    SUCTION RETRACTORS
    MURSE RETRACTOR
    STERNUM SPREADER AND MITRAL VALVE RETRACTOR
    I.M.A. RETRACTOR
    UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
    SPRING RETRACTOR
    STERNUM SPREADER, PEDIATRIC
    SELF-RETAINING SOFT TISSUE RETRACTOR
    HIP, FEMUR AND HUMERUS RETRACTOR
    SUCTION RETRACTOR
    ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000
    OMNI-TRACT CORRAL RETRACTOR
    STERI-TRACTOR WOUND RETRACTOR
    RAYLOR(TM) PROTECTIVE RETRACTOR

    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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