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

    DEKA ACE Pump System

    K Number: K213536 · Decision Jul 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    13
    Review Days
    627

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    Basic Information

    Device Name
    DEKA ACE Pump System
    K Number
    K213536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research and Development
    Date Received
    November 5, 2021
    Decision Date
    July 25, 2023
    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 Deka Research and Development

    K Number Device Name
    K261672 twiist Automated Insulin Delivery (AID) System
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    K243841 Sparta Infusion Set for Insulin
    K240920 HemoCare Bicarbonate Concentrate Set (BCS)
    K233557 HemoCare Hemodialysis System
    K240256 Remunity System
    K241178 DEKA ACE Pump System
    K234055 DEKA Loop
    K233952 DEKA ACE Pump System
    K232316 DEKA Infusion System, DEKA Administration Set
    Search all 13 clearances from Deka Research and Development →