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510(k) Data Aggregation

    K Number
    K253512

    Validate with FDA (Live)

    Device Name
    MiniMed Go App
    Manufacturer
    Date Cleared
    2026-01-08

    (63 days)

    Product Code
    Regulation Number
    868.1890
    Age Range
    2 - 120
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MiniMed Go app is indicated for people with diabetes or their caregivers. The indicated patient population varies based on the combination of connected CGM and injector.

    • Simplera sensor only: Diabetes patients ages 18 years and older
    • InPen smart insulin pen only: Diabetes patients ages 7 years and older, or younger patients under the supervision of an adult caregiver
    • Simplera sensor and InPen smart insulin pen: Diabetes patients ages 18 years and older
    • Instinct sensor and InPen smart insulin pen: Diabetes patients ages 7 years and older, or patients ages 2 to 6 years under the supervision of an adult caregiver

    The dose calculator of the MiniMed Go app is indicated for the management of diabetes by people with diabetes for calculating an insulin dose based on user entered data, most recent glucose value and active insulin.

    To calculate a recommended insulin dose, a healthcare professional must provide patient-specific therapy settings including glucose target, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

    For an insulin dose based on fixed or variable meal sizes, a healthcare professional must also provide patient-specific fixed doses or meal sizes to be programmed into the software prior to use.

    When connected to a CGM, the app supports display of Sensor Glucose (SG) values and trend arrows. When connected to the InPen smart insulin pen, the app supports automatic logging of insulin doses, tracking of active insulin, and a dose calculator. The app also supports alerts or reminders for low glucose, high glucose, and insulin doses.

    Device Description

    The MiniMed Go App is a software-only mobile application intended to connect with compatible Continuous Glucose Monitors (CGMs) – including the Simplera Sensor and Instinct Sensor, and the InPen smart insulin injector. The App enables people with diabetes to manage their therapy through data visualization, insulin dose calculation, and event logging. The App can be installed on compatible mobile devices, enabling users to effectively manage their diabetes. The compatible devices include the user's Android/iOS mobile phones or the App Manager, a compatible display device configured to host Medtronic MiniMed applications.

    The App functions as the primary display and control interface for the InPen and connected CGM systems, consolidating device management, data visualization, and alert functions within a single software platform. It replaces the standalone CGM applications and serves as the central interface through which users manage connected devices and receive CGM, InPen and other system notifications. This integration provides a unified platform that supports diabetes therapy management and improves the overall user experience through consolidated device interaction.

    AI/ML Overview

    N/A

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