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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: IKN FDA class 2

    Electromyograph, Diagnostic

    Physical Medicine

    View full classification →

    A Diagnostic Electromyograph is a device used in Physical Medicine and neurology to record electrical activity produced by skeletal muscles, assisting in the diagnosis of neuromuscular disorders, nerve injuries, and conditions such as carpal tunnel syndrome and ALS. 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 IKN, regulated under 21 CFR 890.1375, 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

    50+ matches
    K Number
    Device Name
    Natus VikingQuest
    ViMove2
    Cadwell Sierra Summit, Cadwell Sierra Ascent
    ViMove
    VIMOVE
    PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
    MYOVISION 3.0 WIREFREE SYSTEM
    CMAP PRO
    FOCUS EMG DEVICE
    CERSR ELECTROMYOGRAPHY SYSTEM
    UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
    NEMUS SYSTEM; NEMUS PC PERIPHERAL
    INSIGHT DISCOVERY
    XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
    COMPREHENSIVE NEUROMUSCULAR PROFILER
    CWAS 1000
    INSIGHT MILLENNIUM III
    NIM-PRS
    ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
    PHYSICAL MONITORING REGISTRATION UNIT
    NEUROPACK MICRO, MODEL MED-9100A SERIES
    COMBINED PHYSIOLOGICAL MONITORING SYSTEM
    ACCUWARM EMG HEAT LAMP
    NEURO SCAN MEDICAL SYSTEMS A4000
    NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
    MA-300 ELECTROMYOGRAPHY SYSTEM
    JE 2000
    CERSR ELECTROMYOGRAPHY SYSTEM
    SYNERGY IOM SYSTEM
    TOENNIES NEUROSCREEN SYSTEM
    MLS ELECTROMYOGRAPHIC PREAMPLIFIER
    ADVANTAGE EMG SYSTEM, MODEL #A100
    ADVANTAGE 3000
    EXCEL EMG
    COMPUTER DYNO/GONIO/MYO GRAPHY
    B & L ELECTRODE
    INTEGRATED MOVEMENT ANALYZER
    STC DIAGNOSTIC 8000
    NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
    PHASIS ELECTROMYOGRAPH
    CAVOMAT
    EMG ACCESSORY FOR POSTUROGRAPHY
    SPACE(TM) 7500
    EMG NAVIGATOR & EMG TRAVELER
    NICOLET NEUROPORT/ACE SYSTEM
    NICOLET VIKING II SYSTEM
    ADR-2000 AMBULATORY DATA RECORDING SYSTEM
    AL-200B MUSCLE ACTIVITY INTEGRATOR
    MODIFIED NICOLET VIKING SYSTEM
    SPINOSCOPE

    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

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