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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: DRM FDA class 2

    Compressor, Cardiac, External

    Cardiovascular

    View full classification →

    The External Cardiac Compressor is a cardiovascular resuscitation device that mechanically applies rhythmic pressure to the chest to maintain circulation during cardiac arrest when manual CPR cannot be sustained consistently. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRM and it is regulated under 21 CFR 870.5200 within the Cardiovascular medical specialty.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    AutoPulse NXT Resuscitation System
    RMU-2000 Automated Chest Compression System
    LUCAS 3 Chest Compression System
    LUCAS 3 Chest Compression System
    ROSC-U Mini Chest Compressor (RMCC)
    RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
    AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
    MINIATURIZE CHEST COMPRESSOR (MCC)
    LUCAS 2
    AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
    THUMPER, MODEL: 1008
    AUTOPULSE RESUSCITATION SYSTEM MODEL100
    MODIFICATION TO LUCAS
    HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
    LUCAS
    ENERTRON CPR JACK
    AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
    MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
    AUTOPULSE RESUSCITATION SYSTEM
    AUTOPULSE, MODEL 100
    THUMPER
    THUMPER CARDIOPULMONARY RESUSCITATOR
    CAD-2000 CARDIAC ASSIST DEVICE
    HASKEL CPR
    HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
    HUNTLEIGH FLOWPAC FP2000
    SWELL-RELIEF
    MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
    THUMPER CARDIOPULMONARY RESUSCITATOR 1005
    FINE NEEDLE ASPIRATION DEVICE
    KEYMED SIGMOIDOSCOPE SUCTION UNIT
    BUSH NECK W/TAP
    CARDIOPULMONARY RESUSCITATOR
    OXY-QUIK MARK IV OXYGEN INHALATOR
    CARDIOPULMUNARY RESUSCITATOR
    CPR HELPER
    SAVE MOR
    CPR TRAVELER
    PNEUPAC RESUSCITATOR INSTANT ACTION SET
    PNEUPAC TEST SET, PT.#500-A250
    PNEUPAC RESUSCITATOR INSTANT ACTION SET
    PNEUPAC RESUSCITATOR INSTANT ACTION SET
    CPR CONTROL SYSTEM
    HLA-2000
    HLR QUICK-FIT HEART-LUNG RESUSCITATOR

    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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