510(k) · Cleared
Recalled · Class II · 2026MiniMed 780G insulin pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed, Inc. · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on Jul 1, 2025 as substantially equivalent to K232380 (Tandem Diabetes Care, Inc., 2023) and 1 other predicate after an 89-day review. Its family tree reaches back 11 generations to 2001. 3 of the 28 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Jul 1, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 11 generations to K010362 (2001). 23 ancestors in all. 4 later devices descend from it, 3 citing it directly. 3 of the 28 devices in this family, counting this one, have a Class I recall.
- 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 deviceK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- Descendant · 2 generations on · 0 of its ownK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
- Descendant · cites it directly · 0 of its ownK253743 MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · Recalled
- Descendant · cites it directly · 0 of its ownK253470 MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit…Medtronic Minimed, Inc. · 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 deviceK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026 · cites it directly1descendant
- K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026 · 2 generations on0descendants
- K253743MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · cites it directly0descendants
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc. · 2026 · cites it directly0descendants
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) | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | — |
| +1 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | — |
| +2 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | — |
| +1 | K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026 | 1 |
| +1 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | 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 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 2022 | 1 | 1 |
| 2023 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 4 | 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.
3 devices in this family have a Class I recall. 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 QFG device
- #1 K253470 MiniMed 780G Insulin Pump (MMT-1884); MiniMed…score 14.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K232380 | t:slim X2 Insulin Pump with Interoperable TechnologySummary page 5…Class II Predicate Device Information Product Code Predicate Device QFG Tandem t:slim X2 Insulin Pump with Interoperable Technology (K232380) NDC InPen Dose Calculator (K242775)… | 2023 |
| * | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Summary page 5…oduct Code Predicate Device QFG Tandem t:slim X2 Insulin Pump with Interoperable Technology (K232380) NDC InPen Dose Calculator (K242775) Page 1 of 15… | 2024 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2026 | Class II | Z-2980-2026 | Process design | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia… |
| Jul 13, 2026 | Class II | Z-2982-2026 | Process design | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia… |
| May 27, 2026 | Class II | Z-2698-2026 | Software design | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by… |
| Feb 13, 2026 | Class II | Z-1741-2026 | Device Design | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site… |
| Jan 30, 2026 | Class II | Z-1635-2026 | Software change control | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due… |
| Nov 2, 2025 | Class II | Z-1238-2026 | Process design | A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Direct predicate · ◆ in the 2023 ancestors bar of FIG. 11 Class I recall
- K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. · 2022 · 2 generations back · ◆ in the 2022 ancestors bar of FIG. 11 Class I recall
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · 3 generations back · ◆ in the 2020 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 23 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K253701 (Medtronic Minimed, 2026) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K232380.
How does its category compare?
All QFG devicesQFG Alternate Controller Enabled Insulin Infusion Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QFG
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFG
44in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFG
8so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · QFG
324,360in 2025
MAUDE reports naming product code QFG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 30,522 |
| 2021 | 0 | — | 0 | 74,701 |
| 2022 | 2 | — | 1 | 129,119 |
| 2023 | 9 | 150 | 1 (1) | 188,014 |
| 2024 | 5 | 89 | 0 | 273,180 |
| 2025 | 5 | 44 | 3 (1) | 324,360 |
| 2026 | 6 | 103 | 8 (1) | — |
What is it indicated for?
The MiniMed 780G insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The MiniMed 780G insulin pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The MiniMed 780G insulin pump contains a bolus…
Read the full statement (109 words)
The MiniMed 780G insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The MiniMed 780G insulin pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.
The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.
The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251032: MiniMed 780G insulin pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251032
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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