BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    DBLG2

    K Number: K251152 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    249

    Basic Information

    Device Name
    DBLG2
    K Number
    K251152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1356
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diabeloop
    Date Received
    April 14, 2025
    Decision Date
    December 19, 2025
    Product Code
    QJI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QJI Interoperable Automated Glycemic Controller

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