BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medical Mesh Nebulizer (AirICU Max+)

    K Number: K251584 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    293

    Basic Information

    Device Name
    Medical Mesh Nebulizer (AirICU Max+)
    K Number
    K251584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AIRICU, Inc.
    Date Received
    May 23, 2025
    Decision Date
    March 12, 2026
    Product Code
    SFP
    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
    SFP Ventilator-Compatible Nebulizer

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