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

    Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

    K Number: K250168 · Decision Dec 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    2
    Review Days
    343

    Basic Information

    Device Name
    Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
    K Number
    K250168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lucas Lifecare
    Date Received
    January 21, 2025
    Decision Date
    December 30, 2025
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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