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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: DWA FDA class 2

    Control, Pump Speed, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    The Cardiopulmonary Bypass Pump Speed Control is a life-sustaining cardiovascular device used to regulate the rotational speed of blood pumps within the extracorporeal circuit, controlling the flow rate of blood delivered to the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWA and it is regulated under 21 CFR 870.4380 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    INSPIRA ART100
    Anivia SG1000 Pump Console
    Anivia SG1000 Pump Console
    Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
    CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
    CentriMag Acute Circulatory Support System
    BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
    CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
    SORIN CENTRIFUGAL PUMP 5 (CP5)
    STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
    LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
    LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
    STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
    LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
    LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
    LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
    BIO-CONSOLE 560
    BIO-CONSOLE, MODEL 560
    TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
    LEVITRONIX CENTRIMAG PRIMARY CONSOLE
    BIO-CONSOLE, MODEL 560
    STOCKERT SCP RHYTHM
    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
    CENTRIFUGAL PUMP
    BARD ISOFLOW BLOOD PUMP
    3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
    MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
    BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
    MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150
    MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
    MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
    MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D
    BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
    BIO MEDICUS BIO CONSOLE 540
    BIO PACK MODEL 200
    GAMBRO PULSATILE MONITOR PLM 10-200
    MODEL 1812 CONTROL CONSOLE, ACCESSORIEX

    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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