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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: CAI FDA class 1

    Circuit, Breathing (W Connector, Adaptor, Y Piece)

    Anesthesiology

    View full classification →

    The Breathing Circuit with Connector, Adaptor, and Y-Piece is an anesthesiology device consisting of interconnected tubing and junction components that form the patient breathing circuit used during anesthesia or assisted ventilation. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification requirements. The product code is CAI, regulated under 21 CFR 868.5240, within the Anesthesiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CONDENSATE COLLECTION KIT
    UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
    UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
    PRIMA COAXIAL CIRCUITS
    PRIMA ADULT GAS SAMPLING CIRCUITS
    PRIMA MAPLESON D CIRCUIT
    PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
    PRIMA PEDIATRIC ANESTHESIA CIRCUITS
    PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
    PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
    SPIRO-FLEX
    NEONATAL BREATHING CIRCUIT MODIFICATION
    MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS
    PRIMA, INC. ADULT ANESTHESIA CIRCUIT
    PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING
    CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING
    CONNECTORS AND AIRWAY EXTENSIONS
    CORRUGATED TUBING
    KARL STORZ LARYNGOSCOPE ACCESSORIES
    M.A.G. INC. BREALTHING BAGS
    PEDIATRIC ANESTHESIA CIRCUITS
    M.A.G. INC. HYPERINFLATION SYSTEM
    GAS SAMPLING LINES AND CONNECTORS CIRCUITS
    VOLUME VENTILATOR
    M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS
    M.A.G. INC. GUEDEL AIRWAYS
    M.A.G. INC. COAXIAL CIRCUITS
    M.A.G. INC. MAPLESON D CIRCUITS
    M.A.G. INC. ADULT GAS SAMPLING CIRCUITS
    M.A.G. INC. VENTILATOR HOSES
    M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS
    M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS
    M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT
    M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
    ADULT ANESTHESIA BREATHING CIRCUIT
    MAPLESON D CIRCUIT
    ADULT ANESTHESIA BREATHING CIRCUIT KITS
    ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS
    MALE/MALE LUER TRANSFER TUBING
    DUAL VALVED RESPIRATORY T
    BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE
    EASYFLOW AIRWAY ADAPTER
    BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE
    THE INFANT FLOW SYSTEM
    ADULT ANESTHESIA BREATHING CIRCUIT
    GAS SAMPLING LINES AND CONNECTORS
    GAS SAMPLING LINES AND CONNECTORS
    PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS
    PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR.
    ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS

    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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