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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: KXK FDA class 2

    Source, Brachytherapy, Radionuclide

    Radiology

    View full classification →

    The Radionuclide Brachytherapy Source is a radiation-emitting device implanted at or near a tumor site to deliver targeted radiation therapy for the treatment of cancer, using radioactive isotopes encapsulated within seeds, wires, or other delivery formats. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXK, regulated under 21 CFR 892.5730, in the Radiology medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RadianceTx Radionuclide Brachytherapy Source
    GammaTile
    Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
    GammaTile
    CivaDerm
    GammaTile
    GammaTile
    Sirius MRI Marker NS
    LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
    SMD-Sr90-DA Radionuclide Brachytherapy Source
    Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
    SPEC Model M23
    SPEC Model M13
    SPEC Model M16
    VariSeed 9.0
    SMD Sr90-1 Radionuclide Brachytherapy Source
    I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
    Lesion-Loc Iodine I-125 Seed/Needle
    ANT MODEL 1
    CIVA SHEET PD-103
    ISOSEED
    BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
    SPEC MODEL M15
    CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
    MRI MARKER
    BEST LOCALIZATION NEEDLE WITH I-125 SEED
    RAPID STRAND RX
    ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
    PRE-LOADED GOLD VISICOIL CK MARKER
    RADIOACTIVE SEED LOCALIZATION NEEDLE
    GLIASITE RTS
    AOS ORION IR-192 SOURCE CABLE
    BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
    I-SEED
    SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
    RADIONUCLIDE BRACHYTHERAPY SOURCE
    ACU007S
    ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
    PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
    PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
    SPEC MODEL M-31
    WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
    CIVASTRING PD-103
    POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
    PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
    AOS MARKER SEEDS
    IMPLANT SCIENCES CORP. MODEL HDR 4454
    BRACHYSCIENCES STRANDPORT
    RAPID STRAND RX

    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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