510(k) · Cleared
Recalled · Class I · 2026t:slim X2 Insulin Pump with Interoperable Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care, Inc. · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on Nov 3, 2023 as substantially equivalent to K203234 (Tandem Diabetes Care, Inc., 2022) after an 87-day review. Its family tree reaches back 3 generations to 2019. 3 of the 10 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- Nov 3, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180058 (2019). 6 later devices descend from it, 2 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 2 generations backK201214 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 1 generation backK203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect…Tandem Diabetes Care, Inc. · 2022 · Recalled (Class I)
- This deviceK232380 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- Descendant · 3 generations on · 0 of its ownK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
- Descendant · 2 generations on · 0 of its ownK253743 MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · Recalled
- Descendant · 2 generations on · 0 of its ownK253470 MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit…Medtronic Minimed, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · cites it directly4descendants
- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026 · 2 generations on1descendant
- K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026 · 3 generations on0descendants
- K253743MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · 2 generations on0descendants
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −2 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | Class I |
| −1 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022 | Class I |
| 0 (this device) | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | — |
| +1 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +2 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | — |
| +3 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | — |
| +2 | K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026 | 1 |
| +2 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 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 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 |
|---|---|---|---|
| * | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Summary page 5…atory class II Predicate devices t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app (K203234) Intended Use The t:slim X2 Insulin Pump with Interoperable Technology (the Pump) is intended for the subcutaneous delivery of… | 2022 |
| † | K193483 | Basal-IQ Technology | 2020 |
| † | K200467 | Control-IQ Technology | 2020 |
| † | K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | 2023 |
What descends from it? (6)
2 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 16, 2026 | Class II | Z-3330-2026 | Software Design Change | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM)… |
| Jan 30, 2026 | Class II | Z-1636-2026 | Process change control | The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to… |
| Jul 3, 2025 | Class II | Z-2621-2025 | Software design | an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. |
| Feb 27, 2025 | Class I | Z-1519-2025 | Software Design Change | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV)… |
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.
- K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. · 2022 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K251032 (Medtronic Minimed, Inc., 2025) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K203234.
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. 2023, 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 t:slim X2 Insulin Pump with Interoperable Technology (the 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 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 pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use in individuals 2 years of age and greater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232380: t:slim X2 Insulin Pump with Interoperable Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232380
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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