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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: BZE FDA class 2

    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    Anesthesiology

    View full classification →

    The Heater, Breathing System W/Wo Controller is a device that warms gases within a respiratory breathing circuit to prevent hypothermia of the airways and maintain appropriate gas temperatures during ventilation; it is distinct from humidifiers and nebulizers. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BZE, regulated under 21 CFR 868.5270 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    43 matches
    K Number
    Device Name
    Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
    Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
    VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
    Sunset Heated CPAP Tube
    Neonatal ConchaSmart Breathing Circuits
    AirLife Adult Heated Wire BiPAP/NIV Circuit
    AirLife Adult Heated Wire Circuit
    FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
    Hybernite RT
    AirLife Infant Heated Wire Circuit
    AirLife Infant Single Limb Heated Wire Circuit
    Flexicare Heated Wire Breathing Systems
    RESPIRONICS REUSABLE HEATED TUBING
    ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
    DUAL HEATED INFANT VREATHING CIROUITS
    RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
    INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
    HYBERNITE RAINOUT CONTROL SYSTEM
    RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
    MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
    AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
    CRITERION, CRITERION I.V., MODIFIED
    HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
    HPD HEATER BASES
    ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
    FLEXHTR-1
    PROTOLOGIC MODEL SER-1
    BREATHING CIRCUIT W/HEATED WIRE
    DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
    CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
    SIMPLEX UNIVERSAL HEATED TUBING SLEEVE
    VAPOR-PHASE HEATED WIRE CONTROLLER
    HEATER WIRE BREATHING CIRCUIT
    DISPOSABLE HEATED WIRE LOOPS 48 AND 72
    ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
    RESPIRATORY GAS HUMIDIFIER
    ARM-A-VIAL LV HEATER-BREATHING SYS
    TROPIC AIR HEAT-ECHANGER BREATHING AID
    ANALOR FOUR-ORAL SURGERY MODEL
    TEMPERATURE CONTROLLER MODEL 17000
    CONTROLLER, SERVO, INSPIRON
    TA-2 TEMPERATURE ALARM
    RESP. AIR TEMP. CONTROL & HAZARD MON.

    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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