BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

    K Number: K253479 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    70
    Review Days
    66

    Basic Information

    Device Name
    Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
    K Number
    K253479
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Healthcare, Ltd.
    Date Received
    October 14, 2025
    Decision Date
    December 19, 2025
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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