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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: GYB FDA class 2

    Media, Electroconductive

    Neurology

    View full classification →

    Electroconductive Media is a conductive gel or paste applied between recording electrodes and the skin or scalp to reduce impedance and improve signal quality during neurological diagnostic procedures such as EEG or EMG. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GYB under regulation 21 CFR 882.1275 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Jmoon Conductive Gel
    Avologi Gel Primer (Model: Av25)
    Conductive Gel
    Conductive Gel
    EEG-acp
    AC Cream - Conductive paste
    GT5 conductive & abrasive gel
    DR-HO'S Electro Therapy Conductive Gel
    Elefix V Paste for EEG & EMG
    SAC2 - Electrode Cream
    Tech Dots - Adhesive and conductive gel
    EndyGel
    NuFACE Gel Primer
    ELECTRO-GEL
    THERA-CREAM, MODEL TCT004
    CONDUCTIVE EEG ELECTROLYTE
    LEKTROGEL, MODEL LK3001
    HOME CARE JELLY
    CONDUCTIVE GEL
    MAVIDON MEDICAL ELECTRODE JELLY
    CONDUCTIVE GEL FOR ULTRASOUND
    STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
    BATCH #6060 CONDUCTIVE GEL
    MODEL 1700, HYDRO PREP
    HYDROPREP GEL
    ECOGEL 300 TENS GEL
    MEDI-TRACE DEFIB PADS
    GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
    GRAHAM-FIELD CONDUCTIVE ECG SPRAY
    GRAHAM-FIELD SALINE ELECTROLYTE GEL
    TEN-20 CONDUCTIVE PASTE GEL
    OMNI PREP GEL
    LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
    CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON
    ELECTROCONDUCTIVE MEDIA
    TENS CONDUCTIVE MEDIA PAD
    CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
    TENS PREP
    TEN20 CONDUCTIVE
    CONDUCTIVITY GEL
    CONDUCTIVITY GEL
    SKIN PURE
    ELEFIX ELECTRODE CREAM
    CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
    LIQUA-SONIC GEL
    ECG-GEL ELECTRODE GEL
    MEDICOTEST ELECTRODE PASTE
    KENZ-GELECT GEL PAD
    KENZ-GELECT
    ZEE ELECTRODE-GEL

    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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