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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: BZA FDA class 1

    Connector, Airway (Extension)

    Anesthesiology

    View full classification →

    The Connector, Airway (Extension) is a device used to extend or join components of an anesthesia or ventilator breathing circuit, maintaining the integrity of the gas pathway between the patient's airway and the ventilator or gas source. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BZA, regulated under 21 CFR 868.5810 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TRACH-ASSIST
    SURELOC CIRCUIT CONNECTOR
    DISPOSABLE FLEX TUBE
    UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
    NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
    DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
    PRIMA, INC. VENTILATOR HOSES
    PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
    PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
    AIRWAY CONNECTOR WITH FLEX TUBE
    THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR
    DOUBLE TRACH SWIVEL CONNECTOR
    DOUBLE TRACH SEIVEL CONNECTOR
    DOUBLE TRACH SWIVEL CONNECTOR
    MAG CONNECTORS AND AIRWAY EXTENSIONS
    CONNECTORS AND AIRWAY EXTENSIONS
    CONNECTORS AND AIRWAY EXTENSIONS
    CONNECTORS AND AIRWAY EXTENSIONS
    CONNECTORS AND AIRWAY EXTENSIONS
    MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
    DURALIFE
    OXYGEN SWIVEL ADAPTER (PLASTIC)
    ENTENDED LINE ACCESSORIES & CONNECTORS
    CATHETER MOUNTS -- MODIFICATION
    DURALIFE(TM)
    TRACH T ADAPTER
    FLEX-ELBOW
    ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
    CATHETER MOUNTS
    ULTRASET CATHETER
    M.D.I. ADAPTER
    BAXTER BAFFLED TEE ADAPTER
    AEROVENT
    SHILEY ELBOW 15MM SWIVEL CONNECTOR
    INTERTECH METERED DOSE ELBOW
    E.T. PUFFER
    BODAI M.D.D. ADAPTOR(TM)
    NEOTECH UNIVERSAL ADAPTER
    FLEX TUBE
    BODAI NEO2-SAFE(TM)
    MEDICOMP STRAIGHT SWIVEL ADAPTOR
    TILSON TRACH GUARD
    CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR
    MEDICOMP INHALANT MASK ELBOW
    SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
    DOUBLE LUMEN E T ADAPTOR
    AEROSOL-T
    UNI-JET CONNECTOR
    INSPIRON DOUBLE SWIVEL TRACH ADAPTER
    90 DEGREE ELBOW & STRAIGHT CONNECTOR

    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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