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

    iLet® ACE Pump

    K Number: K231485 · Decision Jun 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    29

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    iLet® ACE Pump
    K Number
    K231485
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beta Bionics, Inc.
    Date Received
    May 23, 2023
    Decision Date
    June 21, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QFG), ordered by most recent decision date.

    twiist Automated Insulin Delivery (AID) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    iLet ACE Pump

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MiniMed Flex pump

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tandem Mobi insulin pump with interoperable technology

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    iLet ACE Pump

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Beta Bionics, Inc.

    K Number Device Name
    K253976 iLet ACE Pump
    K252770 iLet ACE Pump
    K232224 iLet® Dosing Decision Software
    K220916 iLet® Dosing Decision Software
    K223846 iLet® ACE Pump