BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Aerogen Pro-X1 Controller System

    K Number: K251615 · Decision Sep 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    98

    Basic Information

    Device Name
    Aerogen Pro-X1 Controller System
    K Number
    K251615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerogen, Ltd.
    Date Received
    May 27, 2025
    Decision Date
    September 2, 2025
    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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