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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: KFM FDA class 2

    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

    Cardiovascular

    View full classification →

    Non-Roller Type Cardiopulmonary Bypass Blood Pump is a device used during open-heart surgery to maintain circulation of the patient's blood through the extracorporeal bypass circuit when the heart is stopped, using a pumping mechanism other than a roller, such as a centrifugal pump. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KFM, regulated under 21 CFR 870.4360, within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
    Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
    LifeSPARC System
    Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
    Capiox iCP Centrifugal Pump
    Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
    FloPump 57mL Centrifugal Pump
    Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
    Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
    Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
    Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
    Revolution Centrifugal Blood Pump
    LifeSPARC Pump, LifeSPARC Controller
    FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
    AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
    QUADROX-IR ADULT AND SMALL ADULT
    SARN CENTRIFUGAL PUMP
    TANDEMHEART PUMP
    AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
    AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
    AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
    LIFEBRIDGE
    IMPELLA CONTROLLER WITH FLOW CONTROL
    LIFEBRIDGE
    IMPELLA CONTROLLER
    AFFIITY CP CENTRIFUGAL BLOOD PUMP
    ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
    LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
    MECC SET WITH BIOLINE COATING
    IMPELLA 5.0 CATHETER FAMILY
    TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
    ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
    ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
    IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
    CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
    ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
    LEVITRONIX CENTRIMAG BACK-UP CONSOLE
    ECC.O SYSTEM
    TRILLIUM BIOPUMP PLUS, MODEL BPX80T
    NOVOSCI READY SYSTEM, MODEL RS-200
    IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
    IBC FLOPUMP WITH GBS COATING
    IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
    LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
    JOSTRA MECC SYSTEM
    LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
    CARDIOVENTION CORX SYSTEM, MODEL FG 0001
    SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
    COBE REVOLUTION

    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

    Commonly searched
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