Inpen™
KIT MMT-105NNGYNA Inpen Novonordisk Grey
2manufacturers in China registered for this device type
5catalogue 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) | K201337 |
| Record published | 2024-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMT-105NNGYNA | In distribution | |
| MMT-8060 | In distribution | |
| MMT-8061 | In distribution | |
| MMT-105ELPKNA | In distribution | |
| MMT-105ELBLNA | 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 |
| TempoSmart | Welldoc | 4 |
| LivingConnected Diabetes | 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
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Minimed | 510(k) number | 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 |
| Medtronic Minimed | 510(k) number | 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 |
| Medtronic Minimed | 510(k) number | 2025-03-04 | Class II | Mixed-up of materials/components | Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. I | 8,986 |
| Companion Medical, Inc. | 510(k) number | 2022-11-08 | Class II | Software design | Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or i | 140 |
Recalls
1 of these is 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 |
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.