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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: GWE FDA class 2

    Stimulator, Photic, Evoked Response

    Neurology

    View full classification →

    The Stimulator, Photic, Evoked Response is a neurological device that delivers controlled flashes of light to a patient to elicit visual evoked potentials (VEPs), which are recorded to assess the functional integrity of the visual pathways in the brain. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GWE, regulated under 21 CFR 882.1890 in the Neurology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    E3 and Profile
    Vision Monitor- MonCvONE
    LED PHOTIC System
    Vision Monitor - MonpackONE
    Nurochek System
    Natus Photic Stimulator
    RETeval Visual Electrodiagnostic Device
    ADHERENT VISUAL STIMULATOR GOGGLES
    VISIONSEARCH 1
    DIOPSYS NOVA VEP VISION TESTING SYSTEM
    LIFELINES PHOTIC STIMULATOR
    NEUCODIA
    GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
    ENFANTTM
    RETISCAN, RETIPORT
    ACCUMAP AUTOMATIC PERIMETER
    XLTEK LED GOGGLES, MODEL LED-01
    DA VINCHI EMG/EP ISA1004EP
    EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
    KILOWIN
    TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
    ADVANTAGE EP
    FATIGMETER
    TECA/MEDELEC MISTRAL
    PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
    MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM
    TECA NEUROPTO WITH OS-5 STIMULATOR
    V100 VISUALLY EVOKED POTENTIAL MONITOR
    MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
    MACULOSCOPE(TM)
    MODIFIED BRAIN ATLAS III
    L.E.D. GOGGLES, MODEL 580-LEDGOG
    WAVE GATE
    VPS 2250, CSU2250 & VFU 2250
    SIEGEN VISUAL STIMULATOR
    PHOTIC STIMULATOR TM-3030-70
    SLS 3500 LED VISUAL STIMULATOR
    LED STIMULATOR LS-05
    EVOKED POTENTIAL SYSTEM 2000
    EVOKED 3500 POTENTIAL SYSTEM
    BIOLOGIC SYSTEM BL 101
    MODEL S10VS VISUAL STIMULATOR
    VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
    ESG-1 (EVOKED RESPONSE STIMULUS GENER)
    STIMULATOR MODEL SSS-1101
    STIMULATOR, NIC-106 VISUAL
    GENERATOR, MODEL VG-1
    MODEL 7320 VISUAL STIMULATOR
    TECA VS6 VIDEO STIMULATOR

    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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