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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: CAF FDA class 2

    Nebulizer (Direct Patient Interface)

    Anesthesiology

    View full classification →

    The Direct Patient Interface Nebulizer is an anesthesiology device that converts liquid medication into a fine aerosol mist for inhalation directly by the patient, delivering therapeutic agents to the respiratory tract. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification before marketing. The product code is CAF, regulated under 21 CFR 868.5630, within the Anesthesiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
    HeroTracker Sense
    AdheResp Smart Breath-actuated Mesh Nebulizer
    AllNEB
    MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
    Aerogen®Solo Nebulizer System
    Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
    Hudson RCI® AddiPak® Unit Dose Vial
    Portable (Ultrasonic) Nebulizer
    Hudson RCI® TurboMist™ Nebulizer System
    Ochsner Connected Inhaler Sensor
    Monaghan medical filtered mouthpiece kit
    eRapid Nebulizer System
    Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
    Hudson RCI Variable concentration Large Volume Nebulizer (1770)
    Hailie Sensor NF0110
    Vapotherm Aerosol Adapter AAA-2
    Hailie Sensor NF0107 & NF0108
    Hailie Sensor NF0106
    Nebulizer
    Airvo Nebulizer Adapter
    Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
    BreatheSuite MDI V1
    Hailie Sensor NF0109
    Nebulizer Kit
    Pulmogine Vibrating Mesh Nebulizer
    Corrugated tube with mouthpiece accessory
    Ultrasonic Mesh Nebulizer
    AireHealth NebulizerTM
    Portable Mesh Nebulizer
    AeroEclipse* ONE BAN
    GUS831 Compressor Nebulizer
    Propeller Sensor for Symbicort
    Proneb Max
    CapMedic
    Hailie Sensor
    Hailie Sensor
    Hailie Sensor
    Portable Nebulizer
    Intelligent Mesh Nebulizer
    Propeller Sensor for Neohaler
    Smartinhaler
    HOMED Mesh Nebulizer
    MC 300R* Nebulizer
    SmartTouch
    MC 300* Nebulizer
    Portable Nebulizer
    InnoSpire Go
    The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
    SmartTouch

    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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