BEUDAMED
    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: IKT FDA class 2

    Electrode, Needle, Diagnostic Electromyograph

    Physical Medicine

    View full classification →

    A Needle Electrode for Diagnostic Electromyograph is a fine, disposable or reusable needle-type electrode inserted into skeletal muscle tissue to detect and record electrical signals during electromyographic examination, used in the diagnosis of neuromuscular diseases and nerve injuries. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKT, regulated under 21 CFR 890.1385, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    Allergan Botox Needle Electrode
    Myoject Luer Lock Needle Electrode
    Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
    Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
    EMG RECORDING ELECTRODE ASSEMBLY
    TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
    TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
    DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
    AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
    DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
    RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
    RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
    ULTRASHARP CONCENTRIC NEEDLES
    MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
    DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
    STERILE EMG ELECTRODES
    DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
    DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
    FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
    ELECTRODE NEEDLES
    DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
    SLE EMG ELECTRODES AND ACCESSORIES
    TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
    NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
    TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
    DISPOSABLE NEEDLE ELECTRODE
    RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
    DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
    PROTECTRODE SYSTEMS CONCENTRIC
    RE-USABLE MONOPOLAR NEEDLE
    RE-USABLE CONCENTRIC NEEDLE
    NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
    DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
    DANTEC DISPOSABLE CONCENTRIC NEEDLE
    DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
    DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
    DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
    CONCENTRIC ELECTRODE TYPE #13R01, 13R02
    DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
    EMG ELECTRODES AND EXTENSION CORDS
    MEB-5200

    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
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump