MiniMed App
SW MMT-8099 Controller APP Android 1.0.0
2manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
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) | K253701 |
| Record published | 2026-05-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMT-8098 | In distribution | |
| MMT-8099 | 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
3 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 |
|---|---|---|---|---|
| 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 |
| 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.