MiniMed Go App
FDA 510(k) K253512 · Medtronic Minimed
510(k) numberK253512
Submission
- Device name
- MiniMed Go App
- Applicant
- Medtronic Minimed
Los Angeles, CA, US - Received
- November 6, 2025
- Decision date
- January 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
Other 510(k)s with product code NDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254102 | GlucommanderNDC · Traditional | Glytec, LLC | 05/27/2026SE |
| K260910 | EndoTool IV Cloud 1.0NDC · Traditional | Glooko, Inc. | 05/01/2026SE |
| K253281 | UpDocNDC · Traditional | Updoc, Inc. | 12/23/2025SE |
| K252104 | T1D1NDC · Traditional | Comerge AG | 08/20/2025SE |
| K241088 | EndoTool IV (3.1)NDC · Traditional | Monarch Medical Technologies | 12/11/2024SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | Medtronic Minimed | 11/12/2024SE |
| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
| K221924 | Digital RoutinesNDC · Traditional | Gnc Holdings, LLC | 03/15/2023SE |
More from Gnc Holdings, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261962 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Special | 07/09/2026SE |
| K253743 | MiniMed Flex pumpQFG · Traditional | 03/12/2026SE |
| K253701 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Traditional | 02/03/2026SE |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | 01/15/2026SE |
| K253585 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | 01/14/2026SE |
| K251217 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | 08/29/2025SE |
| K251032 | MiniMed 780G insulin pumpQFG · Traditional | 07/01/2025SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | 11/12/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | 07/02/2024SE |
| K210714 | Extended ReservoirLZG · Traditional | 04/06/2022SE |
Questions and answers
When was MiniMed Go App cleared by the FDA?
MiniMed Go App (K253512) received a 510(k) decision of Substantially Equivalent on January 8, 2026, 63 days after the submission was received.
What is the product code of K253512?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.