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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: BTT FDA class 2

    Humidifier, Respiratory Gas, (Direct Patient Interface)

    Anesthesiology

    View full classification →

    The Humidifier, Respiratory Gas (Direct Patient Interface) is a device that adds moisture to respiratory gases delivered directly to a patient's airway during mechanical ventilation or anesthesia, helping to prevent drying of the mucous membranes. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTT, regulated under 21 CFR 868.5450 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HVT 2.0
    FL-10000U Respiratory Humidifier
    Laboratorios Biogalenic Sterile Water for Inhalation, USP
    Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
    Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
    Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
    Laboratorios Biogalenic Sterile Water for Inhalation, USP
    Hudson RCI Comfort Flo® CubCannula™
    Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
    F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
    HFT150
    F&P Optiflow Oxygen Kit (AA451J)
    F&P myAirvo 3
    F&P Optiflow+ Duet Nasal Cannula
    Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
    BONHAWA Respiratory Humidifier
    F&P 820 Humidification System
    AirLife DuoTherm™ Humidification System
    Sterile Water for Inhalation in 1L Flexoval ® bottles.
    F&P 950 Respiratory Humidifier
    F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
    inspired™ VHB20 Heated Humidifier
    F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
    Optiflow Oxygen Kit
    HVT 2.0
    F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
    O2asis Personal Oxygen Humidifier
    F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
    Palladium High Flow Therapy System
    AirSpiral Heated Breathing Tube
    TNI softFlow 50
    Salter Labs Bubble Humidifier
    HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
    Comfort Flo Humidification System
    AirLife Autofill Humidification Chamber
    FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
    HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
    MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
    CONCHASMART COLUMN
    HUMICARE D900
    CONCHASMART BREATHING CIRCUIT
    HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
    RESPIRATORY GAS HUMIDIFIER
    HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
    CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
    MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
    AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
    TRANSCEND HEATED HUMIDIFIER
    MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
    HUMICARE D900

    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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