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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: BZO FDA class 1

    Set, Tubing And Support, Ventilator (W Harness)

    Anesthesiology

    View full classification →

    The Set, Tubing and Support, Ventilator (W Harness) consists of the tubing, connectors, and harness assembly used to deliver gases from a ventilator to a patient's airway, forming the patient circuit of the ventilator system. 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 BZO, regulated under 21 CFR 868.5975 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    UNICOR, INC. CORRUGATED TUBING
    UNICOR, INC. VENTILATOR HOSES
    PRIMA BREATHING BAGS
    PRIMA VENTILATOR HOSES
    PRIMA CUSTOM ANESTESIA CIRCUIT
    PRIMA VOLUMN VENTILATORSS
    INFANT FLOW SYSTEM
    PRIMA, INC. CORRUGATED TUBING
    VOLUME VENTILATOR
    VENTILATOR HOSE
    TUBE, INHALER OXYGEN
    STAR BREATHING CIRCUITS
    PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
    VOLUME VENTILATORS
    PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
    VENTILATOR HOSES
    CLEVELAND TUBING, INC. VENTILATOR HOSES
    DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
    GAS SAMPLING KIT MODIFICATION
    UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
    NEONATAL VENTILATOR CIRCUIT
    EXTENDED LIFE CIRCUITS
    FLOCARE F
    TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
    SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
    CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
    CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
    OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
    PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
    QUICK CONNECT T ADAPTOR
    LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
    BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
    BABYFLEX PATIENT CIRCUIT
    PORTABLE VENTILATOR PATIENT CIRCUIT
    REUSEABLE BREATHING TUBES
    MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
    RAINCOAT
    PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
    END TIDAL CO2 SAMPLING CIRCUIT
    GAS SAMPLING KIT
    VENTILATOR CIRCUITS (VARIOUS TYPES)
    DISPOSABLE VENTILATOR CIRCUITS
    L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
    CO-AX VENTILATOR CIRCUIT
    SAF T FLO VENTILATOR TUBING
    L100D PATIENT CIRCUIT DUAL LINE
    PATIENT BREATHING CIRCUIT
    AVATRON UNIVERSAL ADULT VOL. VENTILATOR
    AVATRON DISPOSABLE I.P.P.B. CIRUCIT
    PATIENT TUBING HYTREL SIEMENS-ELEMA

    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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