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510(k) Data Aggregation

    K Number
    K253074

    Validate with FDA (Live)

    Device Name
    Tandem Mobi insulin pump with interoperable technology
    Manufacturer
    Tandem Diabetes Care, Inc.
    Date Cleared
    2025-11-06

    (44 days)

    Product Code
    QFG
    Regulation Number
    880.5730
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    DEN170088,K200467,K213919,K250798,K241078
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tandem Mobi insulin pump with interoperable technology (the 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 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 pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 2 years of age and greater.

    Control-IQ+ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

    Control-IQ+ technology is not a substitute for your own active diabetes management. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for single patient use and requires a prescription

    Device Description

    The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi mobile application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set.

    The Tandem Mobi mobile application ("mobile app") displays all information from, and is the primary controller of, the pump. Through the mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi mobile application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi mobile application will be made available via the Android Play® App store for Android-compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

    The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

    The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.

    AI/ML Overview

    N/A

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