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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: IWJ FDA class 1

    System, Applicator, Radionuclide, Manual

    Radiology

    View full classification →

    A manual radionuclide applicator system is a brachytherapy delivery system in which radioactive sources are loaded manually into applicators placed within or near the tumor, used for localized radiation therapy of gynecological cancers and other conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWJ, regulated under 21 CFR 892.5650, within the Radiology medical specialty.

    510(k) Clearances

    36 matches
    K Number
    Device Name
    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
    PGK DEVICE (MODIFIED)
    REGANES RADIONUCLIDE SEED MAGAZINE
    N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
    WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
    NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
    N.I.T., INC. NEEDLE GUIDING TEMPLATE
    PROSTATE SEEDING NEEDLE
    MANAN PROSTATE UNI-LOCK
    WEEKS APPLICATOR
    MANAN PROSTATE LOCKING INTRODUCER SET
    MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
    IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
    IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
    COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
    BEST INDUSTRIES CARTRIDGE & GUN
    QUICK SEEDER
    NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
    SDMO APPLICATOR CODE: ASN.8236
    VARIOUS TEMPLATE APPLICATORS
    VARIOUS AFTERLOADING APPLICATORS
    CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
    PLASTIC-GUIDES
    AFTER LOADING DEVICE KIT
    HILARIS-NORI CERVIX APPLICATOR
    WANG FRONT LOADING APPLICATOR
    MICK 200-TP AND MICK TP NEEDLE
    HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
    HILARIS-NORI ENDOMETRIAL APPLICATOR
    KUMAR CERVICAL APPLICATOR
    HENSCHKE AFTERLOADING APPLICATOR
    I-125 IMPLANT GUN
    HEYER-SCHULTE AFTERLOADING CATHETER
    AFTERLOADING GYNECOLOGICAL APPLICATOR
    SCOTT NEEDLE & SCOTT MICK IMPLANTER
    CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.

    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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