# K253512: MiniMed Go App

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Jan 8, 2026 after 63 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010362 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)), Medtronic Minimed (2024) Summary page 4.

## Recalls of this device
- Sep 2, 2026 · Class II · Z-0265-2027: 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 remind
- Jun 16, 2026 · Class II · Z-2778-2026: 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 

## Indications for use
The MiniMed Go app is indicated for people with diabetes or their caregivers. The indicated patient population varies based on the combination of connected CGM and injector. • Simplera sensor only: Diabetes patients ages 18 years and older • InPen smart insulin pen only: Diabetes patients ages 7 years and older, or younger patients under the supervision of an adult caregiver • Simplera sensor and InPen smart insulin pen: Diabetes patients ages 18 years and older • Instinct sensor and InPen smart insulin pen: Diabetes patients ages 7 years and older, or patients ages 2 to 6 years under the supervision of an adult caregiver The dose calculator of the MiniMed Go app is indicated for the management of diabetes by people with diabetes for calculating an insulin dose based on user entered data, most recent glucose value and active insulin. To calculate a recommended insulin dose, a healthcare professional must provide patient-specific therapy settings including glucose target, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed or variable meal sizes, a healthcare professional must also provide patient-specific fixed doses or meal sizes to be programmed into the software prior to use. When connected to a CGM, the app supports display of Sensor Glucose (SG) values and trend arrows. When connected to the InPen smart insulin pen, the app supports automatic logging of insulin doses, tracking of active insulin, and a dose calculator. The app also supports alerts or reminders for low glucose, high glucose, and insulin doses.

Source page: https://510kreport.com/device/K253512
Methodology: https://510kreport.com/methodology