MiniMed Go App

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-0265-2027 FDA Not yet classified ·initiated 2 Sep 2026

  A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose. The issue was caused by a type cast exception during database migration that occurs upon app update to version 1.2.1 causing a silent failure that prevented the creation of new alerts. Failure to receive the long-acting dose reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, inadvertent duplicate dosing may occur, potentially resulting in hypoglycemia.

• • Ongoing Z-2778-2026 FDA Class II ·initiated 16 Jun 2026

  For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.

Trade Name

MiniMed Go

Generic Name

Percutaneous interstitial fluid glucose monitoring system, electrochemical

Device Name

Minimed Go App (OUS iOS)

Model / Reference

MMT-8600

Primary DI / UDI-DI

00199150038954 EUDAMED

00199150038978 GUDID

Basic UDI-DI

0763000B000327286

510(k) Number

K253512 ↗

FDA Product Code

NDC

EMDN Code

W020106019099 Various diabetes monitoring instruments - other

GMDN Term

Percutaneous interstitial fluid glucose monitoring system, electrochemical

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 868.1890

Special Device Type

Software

EU market of registration

Netherlands

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

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See all devices from Medtronic Minimed, Inc. →

• What is the primary purpose of the MiniMed Go App in diabetes management?

  The MiniMed Go App is designed to automate insulin dosing calculations by integrating real-time continuous glucose monitoring (CGM) data with insulin pump systems. It provides personalized dose recommendations to help users with diabetes achieve more precise glucose control through a mobile platform, reducing manual calculations and improving treatment accuracy.

• How is the MiniMed Go App supplied, and does it require sterilization?

  The MiniMed Go App is supplied exclusively as a software application for mobile devices—it is not a physical device and therefore does not require sterilization. Since it is a digital solution, it is neither reusable nor single-use, aligning with its classification as a non-physical medical software tool.

• Is the MiniMed Go App compatible with all insulin pumps or only specific Medtronic systems?

  The MiniMed Go App is specifically designed to work with compatible Medtronic insulin pump systems and CGM devices. It is not intended for use with non-Medtronic pumps or third-party systems, as seamless data synchronization is a core feature of its functionality.

• What regulatory pathways does the MiniMed Go App follow, and how does this affect its use?

  The MiniMed Go App has received FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). These approvals confirm its safety and performance for automated insulin dose calculations when used with authorized Medtronic hardware. Clinicians and users should ensure their specific pump and CGM models are listed as compatible to maintain regulatory compliance.

• Why is the MiniMed Go App classified under Anesthesiology in administrative records, even though it’s for diabetes management?

  The administrative classification under Anesthesiology (as noted in the advisory committee and product code) is based on the regulatory filing category (e.g., NDC product code routing) and does not reflect its clinical indication. The app is explicitly intended for diabetes management—specifically, automated insulin dosing—and its use is tied to Medtronic’s insulin pump and CGM systems, not anesthesia procedures.