MiniMed Go
MiniMed Go is a mobile app for people with diabetes and their caregivers. It connects to compatible Simplera or Instinct glucose sensors and the InPen insulin pen, displaying glucose values…
MiniMed Go is a mobile app for people with diabetes and their caregivers. It connects to compatible Simplera or Instinct glucose sensors and the InPen insulin pen, displaying glucose values and trends and providing dose calculations, insulin logs and reminders according to the connected devices.
The dose calculator uses entered information, the latest glucose value and active insulin. A healthcare professional must first supply patient specific glucose targets, insulin to carbohydrate ratios and sensitivity settings, plus fixed doses or meal sizes when those methods are used.
Listed Item
SW MMT-8601 Minimed GO US Android
Age and Device Compatibility
Simplera use, alone or with InPen, is limited to adults aged 18 or older. InPen alone supports users aged seven or older, with younger users supervised by an adult caregiver. Instinct with InPen supports users aged seven or older and children aged two to six under adult caregiver supervision.
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Medtronic Minimed, United States |
|---|---|
| FDA product code | NDC |
| Device type | Calculator, Drug Dose |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K253512 |
| Record published | 2026-06-14 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 20 to 95 % RH; Storage environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMT-8600 | In distribution | |
| MMT-8601 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welldoc | Welldoc | 16 |
| Insulia | Voluntis | 6 |
| Healthfirst Cares Rx | Welldoc | 6 |
| Bluestar | Welldoc | 6 |
| Healthfirst Cares | Welldoc | 5 |
| Conifer Connect Diabetes | Welldoc | 5 |
| Welldoc Rx | Welldoc | 5 |
| LivingConnected Diabetes Rx | Welldoc | 5 |
| Bluestar Rx | Welldoc | 5 |
| Conifer Connect Diabetes Rx | Welldoc | 5 |
| inpen™ | Medtronic Minimed | 5 |
| TempoSmart | Welldoc | 4 |
Showing 12 of 36. All products under Calculator, Drug Dose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253512 | 2026-01-08 |
| K242775 | 2024-11-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Minimed | 510(k) number | 2026-06-16 | Class II | Software design | 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 mi | 3,465 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-13 | Class II | Software Design Change | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can’t choose to allow notifications to override phone settings when on mute/Do Not Disturb, and pr | 8251 |
| 2025-06-16 | Class II | Under Investigation by firm | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact i | 6816 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.