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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: DTL FDA class 2

    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    The Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, and Fitting is a cardiovascular accessory device used to connect, route, and control the flow of blood and fluids within extracorporeal bypass circuits 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 DTL and it is regulated under 21 CFR 870.4290 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Y-Connector Kit
    Attachable Cath Lab Hemostasis Valve
    Passage Hemostasis Valve
    ROTATING ADAPTERS
    COLIGN
    AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
    CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
    GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
    MEDLINE STOPCOCK AND MANIFOLD
    E-PASS
    TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
    DISPOSABLE HEMOSTATIC Y-CONNECTORS
    CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
    GUARDIAN II NC HEMOSTASIS VALVE
    TERUMO LAUER LOCK ADAPTER
    MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L
    NMI FC
    GATOR CLIPSEAL PLUG
    GUARDIAN II HEMOSTASIS VALVE
    SEDAT MYSHELL LITE
    LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
    CAPIOX CIRCUIT CONNECTORS
    GUARDIAN HEMOSTASIS VALVE
    Y-GLIDE
    HEMOSTASIS VALVE
    Y-CLICK CONNECTOR
    6248VAL ADJUSTABLE VALVE
    GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
    EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
    TERUMO CIRCUIT CONNECTORS
    MYSHELL
    NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
    RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
    IS-1 HEMOSTASIS VALVE, MODEL 6799
    GISH TUBING AND CONNECTORS WITH GBS COATING
    ADAPTERS WITH X-COATING
    LV-1 HEMOSTASIS VALVE, MODEL #6789
    ADAPTERS WITH X-COATING
    COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
    MBA
    COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
    MANIFOLD
    HIGH PRESSURE INJECTION LINES
    NMI VEIN GRAFT PERFUSION SET
    HEMO-VALVE
    MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
    QUEST VEIN GRAFT PERFUSION SET
    BRAUN MANIFOLD
    SCIMED GATEWAY PLUS

    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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