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

    AffloVest® Mobile Airway Clearance Therapy

    K Number: K252849 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    234

    Basic Information

    Device Name
    AffloVest® Mobile Airway Clearance Therapy
    K Number
    K252849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tactile Medical
    Date Received
    September 8, 2025
    Decision Date
    April 30, 2026
    Product Code
    BYI
    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
    BYI Percussor, Powered-Electric

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