510(k) · Cleared
Recalled · Class II · 2026MiniMed Go App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · NDC Calculator, Drug Dose
Cleared on Jan 8, 2026 as substantially equivalent to K242775 (Medtronic Minimed, 2024) after a 63-day review. Its family tree reaches back 11 generations to 2001. It has been recalled 2 times.
- Decided
- Jan 8, 2026
- Review
- 63 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010362 (2001). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 7 generations between
- 3 generations backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- 2 generations backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- 1 generation backK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- This deviceK253512 MiniMed Go AppMedtronic Minimed · 2026
Show all 11 generations
- Root · 11 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 10 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 9 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 8 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 7 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 6 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 5 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 4 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 3 generations backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- 2 generations backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- 1 generation backK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- This deviceK253512 MiniMed Go AppMedtronic Minimed · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −10 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −9 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −8 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −7 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −6 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −5 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −4 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −3 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| −2 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| −1 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
| 0 (this device) | K253512 | MiniMed Go App | Medtronic Minimed | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDC device
- #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Summary page 4…Clinical Chemistry Device Class Class II Predicate Device Information Product Code Predicate Device NDC InPen System App (K242775) Device Description The MiniMed Go App is a software-only mobile application intended to connect with compatib… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2026 | Class II | Z-0265-2027 | Software design | 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 reminder after updating their app to version… |
| Jun 16, 2026 | Class II | Z-2778-2026 | 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 missed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K242775.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (261 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253512 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253512: MiniMed Go App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253512
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026