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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: GXY FDA class 2

    Electrode, Cutaneous

    Neurology

    View full classification →

    The Cutaneous Electrode is a surface electrode placed on the skin for use in neurological monitoring procedures such as electroencephalography (EEG), nerve conduction studies, or evoked potential testing. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXY under regulation 21 CFR 882.1320 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BioWave BioWraps
    Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
    MR Conditional Cup Electrodes
    Tutamen Self Adhesive Electrodes
    myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
    Ceribell Brain Monitor Headband
    Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
    Ceribell Instant EEG Headset
    Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
    Electrotherapy Electrodes
    IceCap product line
    Delphi MCS Electrode Cap
    Electrode Pad
    Wave Electrode (AE02-60); Wave Electrode (AE02-50)
    CAIs Sensor (CAIs-001)
    WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
    Grass® MR Conditional/CT Cup Electrodes
    Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
    Glide (91000-GL-X)
    Amydi-med Disposable Non-invasive EEG electrodes
    Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe
    Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
    Conductive Silicone Rubber Electrode
    Conductive carbon film electrode
    Ceribell Instant EEG Headband
    Starly pad
    Ceribell Instant EEG Headcap
    Motive™ Electrode
    DeltaScan Patch
    Garment Electrodes
    Disposable Non-invasive EEG Sensor
    Self-adhesive Electrode
    Alpha Control Liner System (ACLS)
    EZ-STIK Electrodes
    ControlSeal Electrode (ELSB)
    Self-adhesive Electrode
    Dexus Prosthetics System (Model: MSL1, MSR1)
    Disposable EEG cable
    Self-adhesive Electrode
    Wrap Accessory Electrodes
    Comby EEG Caps
    Adhesive Electrodes
    Adhesive Electrode
    Ceribell Instant EEG Headband
    Metallic Fabric Electrodes
    Electrode Market Disposable Surface Electrodes
    BioWave BioWraps
    Well-Life Garment Electrodes (GM Series)
    NeuroCap (Model DEC22)
    MR Conditional Sticky Pad Electrode

    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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