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

    LifeVac

    K Number: DEN250012 · Decision Mar 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    327

    Basic Information

    Device Name
    LifeVac
    K Number
    DEN250012
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.5400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Lifevac, LLC
    Date Received
    April 11, 2025
    Decision Date
    March 4, 2026
    Product Code
    QXN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QXN Suction Anti-Choking Device As A Second-Line Treatment