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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: DPW FDA class 2

    Flowmeter, Blood, Cardiovascular

    Cardiovascular

    View full classification →

    The Flowmeter, Blood, Cardiovascular is a diagnostic device used to measure blood flow rates in cardiovascular structures, typically employing electromagnetic or ultrasonic techniques, used intraoperatively or in research settings to assess cardiac output and vascular function. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DPW, regulated under 21 CFR 870.2100, within the Cardiovascular medical specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FloPatch FP120
    Elfor-L
    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
    FloPatch FP120
    FloPatch FP120
    GEM FLOW COUPLER Monitor (GEM1020M-2)
    VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
    Bidop 7
    FloPatch (FP120)
    FlowMet
    SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
    FloPatch (FP110)
    FlowMet-R
    iCertainty
    Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
    PeriFlux6000
    CerOX
    Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
    TRANSONIC TISSUE PERFUSION MONITOR
    DELTEX MEDICAL CARDIOQ-EDM+
    CEROX
    SONOTT FLOWLAB(R)
    AUREFLO MONITORING SYSTEM
    DELTEX MEDICAL CARDIOQ EDM
    SENSILASE PAD-IQ
    DOPPLER MONITOR
    MEDISTIM VERIQC SYSTEM
    MOORVMS-PRES PRESSURE CUFF CONTROLLER
    VTI INTRAOPERATIVE DOPPLER SYSTEMS
    CRITIVIEW, MODEL CRV3
    CRITIVIEW
    VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
    SMARTDOP 45 VASCULAR DOPPLER
    QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
    QUANTIX OR VESSEL STABILIZER DEVICE
    SENSILASE PAD 3000
    MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
    SONO TT ULTRASONIC FLOWCOMPUTER
    ECHO SOUNDER EX-101EX 8 MHZ
    ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
    MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065
    QUANTIX/OR DEVICE
    CARDIOQ, MODEL 9051-7005
    CAPIOX CARDIOTOMY RESERVOIR
    VTI 20 MHZ GATED DOPPLER
    QUANTIX/ND DEVICE
    QFLOW 500 PERFUSION MONITORING SYSTEM
    FLOWGUARD DEVICE
    BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T

    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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