510(k) · Cleared
Recalled · Class II · 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 Sep 24, 2025 as substantially equivalent to K232380 (Tandem Diabetes Care, Inc., 2023) after a 194-day review. Its family tree reaches back 4 generations to 2019. 3 of the 5 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Sep 24, 2025
- Review
- 194 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN180058 (2019). No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 3 generations backK201214 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 2 generations backK203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect…Tandem Diabetes Care, Inc. · 2022 · Recalled (Class I)
- 1 generation backK232380 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- This deviceK250792 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −3 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | Class I |
| −2 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022 | Class I |
| −1 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| 0 (this device) | K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K232380 | t:slim X2 Insulin Pump with Interoperable TechnologySummary page 5…ification Name Alternate controller enabled infusion pump Regulation Number 21 CFR 880.5730 Device Class Class II Predicate Device K232380, t:slim X2 insulin pump with interoperable technology I. Device Under Review The Subject… | 2023 |
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 |
|---|---|---|---|---|
| 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… |
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 · ◆ on the line of descent in 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 · ◆ on the line of descent in FIG. 11 Class I recall
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 3 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
- 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 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/K250792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250792: 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 6, 2026. https://510kreport.com/device/K250792
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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