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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: KRI FDA class 1

    Accessory Equipment, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    This device comprises accessory equipment for cardiopulmonary bypass, including ancillary components that support the extracorporeal circulation circuit used during open heart surgery to maintain blood flow and oxygenation while the heart is stopped. It is classified as FDA Class 1, the lowest risk level, subject to general controls only. The product code is KRI, regulated under 21 CFR 870.4200 within the Cardiovascular specialty. No special flags apply.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
    INTERFACE MODULE IDDD
    STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
    AMMEX TUBING ORGANIZER
    CARDIO2 CYCLE
    TUBE GRIP
    NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS
    CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
    CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
    HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
    CPE 2000 CARDIO PULMONARY ERGOMETER
    STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
    STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
    ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
    STABLELINE
    ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
    CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
    GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
    CARDIAC COOLING JACKET
    COBE GAS FILTER
    HOLDER FOR BOS-10, 10S 5S
    TUBE TENDER
    HOLDER FOR MODELS AF-10,1025,1040,5
    SHILEY GAS FILTER
    GASLINE FILTER #GF-10
    HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
    D645-BACTERIOLOGICAL GAS LINE FILTER
    TMO INTEGRATED CIRCUIT SYSTEM
    TEMPERATURE PROBES
    CARDIOPLEGIA COOLING & ADMIN. SETS
    CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
    SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
    DISPOSABLE PARALLEL Y CONNECTORS
    DISPOSABLE GAS LINE FILTER
    DISPOSABLE CONNECTORS
    WILLIAM HARVEY OXYGENATING GAS FILTER
    OXYGENATOR GAS LINE FILTER
    SHILEY QUICK DISCONNECT ASSEMBLY
    SARNO SINGLE POLE MAST
    FILTER, EXTRACORPOREAL BLOOD HOLDER
    PVC QUICK PRIME LINES
    VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR

    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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