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

    MiniMed 780G insulin pump

    K Number: K251032 · Decision Jul 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    MiniMed 780G insulin pump
    K Number
    K251032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Minimed, Inc.
    Date Received
    April 3, 2025
    Decision Date
    July 1, 2025
    Product Code
    QFG
    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
    QFG Alternate Controller Enabled Insulin Infusion Pump

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    Other Clearances by Medtronic Minimed, Inc.

    K Number Device Name
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