BEUDAMED
    Product Code: QFG FDA class 2 21 CFR 880.5730

    Alternate Controller Enabled Insulin Infusion Pump

    Clinical Chemistry

    The Alternate Controller Enabled Insulin Infusion Pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient with basal and bolus drug delivery at set or variable rates, designed to reliably and securely communicate with external devices such as automated insulin dosing systems to allow insulin delivery commands to be received, executed, and confirmed. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 880.5730 in the Clinical Chemistry specialty. The product code is QFG. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    28
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    9
    Years Active
    7

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    Basic Information

    Product Code
    QFG
    Device Class
    FDA class 2
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 28 510(k) clearances via K numbers.

    K Number Device Name
    K261672 twiist Automated Insulin Delivery (AID) System
    K253976 iLet ACE Pump
    K253743 MiniMed Flex pump
    K253470 MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
    K253074 Tandem Mobi insulin pump with interoperable technology
    K252770 iLet ACE Pump
    K250792 t:slim X2 insulin pump with interoperable technology
    K251032 MiniMed 780G insulin pump
    K250930 twiist system
    K234027 embecta Insulin Delivery System
    K241078 Tandem Mobi Insulin Pump with interoperable technology
    K241178 DEKA ACE Pump System
    K240309 Tandem Mobi insulin pump with interoperable technology
    K233952 DEKA ACE Pump System
    K230545 Inessa System
    K232380 t:slim X2 Insulin Pump with Interoperable Technology
    K231826 Omnipod 5 ACE Pump
    K233044 Tandem Mobi insulin pump with interoperable technology
    K213134 Accu-Chek Solo micropump system with interoperable technology
    K213536 DEKA ACE Pump System
    K223213 Tandem Mobi Insulin Pump with Interoperable Technology
    K231485 iLet® ACE Pump
    K223846 iLet® ACE Pump
    K203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
    K203768 Omnipod 5 ACE Pump (Pod)
    K201214 t:slim X2 Insulin Pump with Interoperable Technology
    K191679 Omnipod DASH Insulin Management System with interoperable technology
    DEN180058 t:slim X2 insulin pump with interoperable technology

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.