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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: FMG FDA class 2

    Stopcock, I.V. Set

    General Hospital

    View full classification →

    The I.V. Set Stopcock is a manually operated valve used in intravenous administration sets to control, redirect, or shut off fluid flow between multiple connected lines. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMG, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Qitexio® 4-Way Stopcock (QIT014)
    Three Way Stop Cock
    lntravascular Administration Sets with Stopcock and Manifold
    SafePort(TM) Manifold (or Stopcock)
    Clicky Cross
    TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
    Elcam Stopcocks and Manifolds
    Dynarex Three-Way Stopcock
    ELCAM STOPCOCKS AND MANIFOLDS
    DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
    LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
    DUAL SYRINGE HOLDER
    ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
    ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
    CLAVE STOPCOCK
    SMARTSITE STOPCOCK
    JMS PLANECTA STOPCOCK
    BACSTOP
    ROBERTSITE STOPCOCK
    CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
    TRU-SWAB STOCOCK
    NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
    INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
    ELCAM STOPCOCKS AND MANIFOLDS
    CHURCHILL MEDICAL SYSTEMS STOPCOCK
    4 PORT, 4 WAY STOPCOCK
    MANIFOLD WITH EXTENSION SET
    CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
    PRIMARY IV SET
    TRI-FLOW THREE WAY STOPCOCK
    STOPCOCK MANIFOLD GANGS
    STOPCOCK & LUER LOCK PLUG
    MED-NET STOPCOCKS
    MINIBORE STOPCOCK SET
    ICU STOPCOK WITH EXTENSION TUBING
    STOPCOCK INTRAVENOUS THERAPY
    MULTI-PORT MANIFOLD
    STOPCOCK
    TRUMPET VALVE
    ADVANCE DISPOSABLE STOPCOCK
    TERUFUSION THREE WAY STOPCOCK
    CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
    RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
    TU STOPCOCK
    STERICAP ASSEMBLY AND REPLACEMENT TRAY
    STERICAP STOPCOCK
    VIGGO EXACTA PRESSURE MONITORING KIT
    VIGGO EXACTA PRESSURE MONITORING SYSTEM
    #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
    CHURCHILL 3-WAY STOPCOCK

    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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