LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253743

    Validate with FDA (Live)

    Device Name
    MiniMed Flex pump
    Manufacturer
    Medtronic Minimed, Inc.
    Date Cleared
    2026-03-12

    (108 days)

    Product Code
    QFG
    Regulation Number
    880.5730
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    7 - 120
    Reference & Predicate Devices
    K251032
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MiniMed Flex pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

    The MiniMed Flex pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

    The MiniMed Flex pump is indicated for use in persons 7 years of age and older.

    The MiniMed Flex pump is intended for single patient use and requires a prescription.

    Device Description

    The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The MiniMed Flex pump is intended to be used in conjunction with compatible, digitally connected medical devices (i.e., iAGC and CGM) for the purpose of drug delivery. The MiniMed Flex pump is provided with compatible iAGCs installed, refer to the compatible iAGCs for indications related to iAGC use with MiniMed Flex pump.

    The MiniMed Flex pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump. It is a screenless, tubed pump that houses electronics, a pumping mechanism, and a medication reservoir within the same physical device. It is intended for use with compatible insulin reservoir and insulin infusion set for delivery of basal and bolus insulin according to settings selected or inputs entered by the user or compatible iAGC software based on healthcare provider recommendations.

    The MiniMed Flex pump is an interoperable device that communicates via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The MiniMed Flex pump is able to integrate the compatible MiniMed iAGC algorithms into the pump firmware to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data from a compatible iCGM or a compatible interoperable Medtronic CGM via BLE and transmits the SG and other CGM data to the iAGCs.

    The MiniMed Flex pump is a screenless pump with minimal user interface and manual control capabilities available from the pump itself. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1