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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: BYD FDA class 1

    Condenser, Heat And Moisture (Artificial Nose)

    Anesthesiology

    View full classification →

    The Condenser, Heat and Moisture (Artificial Nose) is a passive device placed in the breathing circuit between the patient's airway and the ventilator or anesthesia system that captures heat and moisture from exhaled gas and returns it to the inhaled gas, reducing airway drying. 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 BYD, regulated under 21 CFR 868.5375 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HEAT & MOISTURE EXCHANGER
    DISPOSABLE HME/FILTER
    HEAT MOISTURE EXCHANGER
    TYPE 1 & 2 (HUMIDAIR I & II)
    WARM N WET HMEF W/LUER ADAPTER
    WARM N WET HME W/LUER ADAPTER
    HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
    HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
    EEE
    HUMID-VENT TRACH-VENT
    HUMID-VENT 2
    HUMID-VENT 1
    FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
    HUMID-VENT FILTER PEDI
    FLEXLIFE
    DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
    HUMID-VENT MICRO
    AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
    FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT
    DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER
    HEAT AND MOISTURE EXCHANGER FILTER (HME)
    DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
    HYGROLIFE
    HEAT AND MOISTURE EXCHANGERS AND FILTERS
    AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF
    VENSHIELD
    HYGROSTER
    TRACHEOLIFE
    HEPA FILTERED HEAT AND MOISTURE EXCHANGER
    KING SYSTEMS HME
    HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION
    AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH
    FHB, FHB-T, FHBFLEX, FHBFLEX-T
    VAPORTEMP HEAT AND MOISTURE EXCHANGER
    5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID
    HEAT MOISTURE CONDENSER
    BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.
    BREATHE EASY
    FLOCARE DRY CAS SAMPLING PORT MODELS
    FLOCARE LF-A
    ARTEMA AQUA+ N
    ARTEMA AQUA+ T & TS
    ARTEMA AQUA+
    ARTEMA AQUA+ FLEX
    INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
    ICOR HCH 4, ICOR HCH 7
    FLOCARE
    FREEVENT (TM)
    BACT-HME (TM)
    HME-10 (TM)

    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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