510(k) · Cleared
Recalled · Class I · 2026t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
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 Feb 15, 2022 as substantially equivalent to K201214 (Tandem Diabetes Care, Inc., 2020) after a 469-day review. Its family tree reaches back 2 generations to 2019. 7 of the 15 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Feb 15, 2022
- Review
- 469 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180058 (2019). 12 later devices descend from it, 2 citing it directly. 7 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 1 generation backK201214 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Recalled (Class I)
- This deviceK203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect…Tandem Diabetes Care, Inc. · 2022
- Descendant · cites it directly · 6 of its ownK232380 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · cites it directly · 4 of its ownK223213 Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK233044 Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK240309 Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K201214 t:slim X2 Insulin Pump with Interoperable…direct predicate · 2020
- K232380 t:slim X2 Insulin Pump with Interoperable…cites it directly · 2023
- K223213 Tandem Mobi Insulin Pump with Interoperable…cites it directly · 2023
- K233044 Tandem Mobi insulin pump with interoperable…2 generations on · 2023
Most influential descendants
Showing 5 of 12 · See all- K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · cites it directly6descendants
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · 2 generations on4descendants
- K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · cites it directly4descendants
- K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · 2 generations on3descendants
- K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −1 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | Class I |
| 0 (this device) | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022 | — |
| +1 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| +2 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +1 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| +2 | K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| +3 | K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 3 |
| 2024 | 2 | 2 |
| 2025 | 3 | 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.
7 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 |
|---|---|---|---|
| * | K201214 | t:slim X2 Insulin Pump with Interoperable TechnologySummary page 4…Pump Regulation Number 21 CFR 880.5730 Device Class Class II Classification Product Code QFG Predicate Device K201214 t:slim X2 Insulin Pump with Interoperable Technology I. Purpose of Traditional 510(k) R… | 2020 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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)… |
| Aug 5, 2025 | Class II | Z-0232-2026 | Software change control | A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic… |
| Mar 5, 2024 | Class I | Z-1609-2024 | Software Design Change | During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain… |
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.
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241078Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K232380 (Tandem Diabetes Care, Inc., 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K201214.
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. 2022, 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 with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203234: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203234
Report an extraction error
Are you the manufacturer?
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