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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: GWJ FDA class 2

    Stimulator, Auditory, Evoked Response

    Neurology

    View full classification →

    The Stimulator, Auditory, Evoked Response is a neurological diagnostic device that generates precisely controlled auditory stimuli to elicit auditory brainstem responses (ABRs) and other auditory evoked potentials, used to assess hearing and auditory pathway integrity. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GWJ, regulated under 21 CFR 882.1900 in the Neurology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Integrity V500 (Integrity, Integrity with VEMP)
    ALGO Pro Newborn Hearing Screener (ALGO Pro)
    QScreen
    ALGO 7i
    GSI Audera Pro
    SmartEP
    Eclipse with VEMP
    ICS CHARTR EP 200 WITH VEMP
    ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
    MADSEN ACCUSCREEN TYPE 1077
    EARPROBE
    HEARLAB ACA
    TYPE 1077 ACCUSCREEN
    CIRCUMAURAL ADHESIVE REPLACEMENT
    TITAN
    EARPROBE
    ICS CHARTR EP 200
    SMARTSCREENER-PLUS2
    ICS CHARTR EP 200
    MAICO MB 11 WITH BERAPHONE PROBE
    VIVOSONIC NEUROSCREEN
    SMART COUPLER, MODEL M015401
    BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
    ALGO 5 NEWBORN HEARING SCREENER
    SMARTEP, MODEL M010000
    INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
    SMART USBLITE, MODEL M011120
    INTEGRITY, MODEL V500
    SMARTEP-ASSR, MODEL M811007
    STACKED ABR FOR NAVIGATOR PRO
    MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
    ALGO 3I NEWBORN HEARING SCREENER
    BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
    ECHO-SCREEN T, TA, TD, TDA, TC
    BIO-LOGIC ABAER CUB
    SABRE COMPAC
    AURIS AEP
    ALGO 3 NEWBORN HEARING SCREENER
    MB 11
    ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
    MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
    SABRE
    INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
    BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
    EXCEL AV STIM 1000
    CHARTR EP
    TECA PREMIERE
    CLARITY SYSTEM II
    ALGO-2 NEWBORN HEARING SCREENER
    SMART-SCREENER (AUDITORY)

    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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