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

    Paptizer 360

    K Number: K252471 · Decision Apr 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    266

    Basic Information

    Device Name
    Paptizer 360
    K Number
    K252471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6993
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LiViliti Health Products Corporation
    Date Received
    August 6, 2025
    Decision Date
    April 29, 2026
    Product Code
    QXQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QXQ Respiratory Accessory Microbial Reduction Device.

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