510(k) · Cleared
Recalled · Class II · 2026MiniMed Flex 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 Mar 12, 2026 as substantially equivalent to K251032 (Medtronic Minimed, Inc., 2025) after a 108-day review. Its family tree reaches back 12 generations to 2001. 3 of the 25 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Mar 12, 2026
- Review
- 108 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K010362 (2001). 24 ancestors in all. No later device cites it as a predicate yet. 3 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 8 generations between
- 3 generations backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- 2 generations backK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- 1 generation backK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- This deviceK253743 MiniMed Flex pumpMedtronic Minimed, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 11 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 10 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 9 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 8 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 7 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 6 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 5 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 4 generations backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- 3 generations backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- 2 generations backK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- 1 generation backK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- This deviceK253743 MiniMed Flex pumpMedtronic Minimed, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −11 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −10 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −9 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −8 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −7 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −6 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −5 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −4 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| −3 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| −2 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
| −1 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| 0 (this device) | K253743 | MiniMed Flex pump | 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 |
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 K251032 MiniMed 780G insulin pumpscore 19.6 · 11 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 |
|---|---|---|---|
| * | K251032 | MiniMed 780G insulin pumpSummary page 7…21 CFR 880.5730 Product Codes QFG Device Panel Clinical Chemistry Device Class Class II Predicate Device K251032 - MiniMed 780G Flex Pump with Interoperable Technology Device Description The MiniMed Flex pump is an alternate controller ena… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-0088-2027 | Under Investigation by firm | Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed… |
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 · 2 generations back · ◆ 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 · 3 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 · 4 generations back · ◆ in the 2020 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K251032.
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. 2026, 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 Flex 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 Flex 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 Flex pump is indicated for use in persons 7 years of age and older.
The MiniMed Flex pump is intended for single patient use and requires a prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253743 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253743: MiniMed Flex pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253743
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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