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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: DRY FDA class 2

    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    The On-Line Blood-Gas Monitor for Cardiopulmonary Bypass is a cardiovascular diagnostic device used during open-heart surgery to continuously measure arterial blood gas levels within the extracorporeal bypass circuit, enabling real-time management of oxygenation and ventilation. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRY and it is regulated under 21 CFR 870.4330 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    CDI OneView Monitoring System
    B-Capta
    Quantum Workstation 12 Elite
    CDI Blood Parameter Monitoring System 550
    Quantum Workstation 12.1
    Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
    Quantum Workstation
    TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
    CDI BLOOD PARAMETER MONITORING SYSTEM 500
    CDI BLOOD PARAMETER MONITORING SYSTEM 500
    M4 MONITOR
    B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
    M3 MONITOR
    BLOOD MONITORING UNIT, MODEL BMU 40
    M3 MONITOR
    M2 MONITOR
    SPECTRUM M2 MONITOR
    TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
    DATA MASTER PERFUSION MONITORING SYSTEM
    3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
    3M CDI H/S CUVETTES WITH HEPARON TREATMENT
    3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
    IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
    IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
    MEDSAT OXYGEN SATURATION SYSTEM
    CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
    CDI(TM) H/S CUVETTE, MODIFICATION
    CDI(TM) 300, 400 & 100, MODIFICATION
    SATURATION/HEMATOCRIT MONITOR SYSTEM
    GOLD GATORS
    APPLICARD (EKG)
    PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
    STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
    STAT-SAT
    GEM-CRIT CHECK
    CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
    CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
    CARDIOMET 4000 GAS MONITORING SYSTEMS
    CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
    GEM-6, WITH COMPONENTS
    HEMATOCRIT-SATURATION MONITOR HSM-100
    COBE SATURATION CELL
    PO 2 LYTRODE
    GAS-STAT MONITORING SYSTEM
    OXYGEN CONSUMPTION MONITOR #OCM-0100
    IN-LINE OXYGEN MONITORING SYSTEM
    OXIMETRIX ACCU SAT CPB

    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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