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 Jun 4, 2020 as substantially equivalent to DEN180058 (Tandem Diabetes Care, Inc., 2019) after a 30-day review. Its family tree reaches back 1 generation to 2019. 7 of the 19 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Jun 4, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180058 (2019). 17 later devices descend from it, 2 citing it directly. 7 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- This deviceK201214 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020
- Descendant · cites it directly · 12 of its ownK203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect…Tandem Diabetes Care, Inc. · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK232380 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 4 of its ownK223213 Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK233044 Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K203234 t:slim X2 Insulin Pump with Interoperable…cites it directly · 2022
- K232380 t:slim X2 Insulin Pump with Interoperable…2 generations on · 2023
- K223213 Tandem Mobi Insulin Pump with Interoperable…2 generations on · 2023
- K233044 Tandem Mobi insulin pump with interoperable…3 generations on · 2023
Most influential descendants
Showing 5 of 17 · See all- K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. · 2022 · cites it directly12descendants
- K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · 2 generations on6descendants
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · 3 generations on4descendants
- K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · 2 generations on4descendants
- K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| 0 (this device) | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| +1 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022 | Class I |
| +2 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| +3 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +2 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| +3 | K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 1 |
| 2023 | 5 | 3 |
| 2024 | 2 | 2 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | DEN180058 | t:slim X2 insulin pump with interoperable technologySummary page 4…21 CFR 880.5730 VII. Device Class Class II VIII. Classification Product Code QFG IX. Predicate Device DEN 180058 t:slim X2 Insulin Pump with Interoperable Technology X. Purpose of Specia… | 2019 |
What descends from it? (17)
See all 172 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… |
| Jul 21, 2025 | Class I | Z-2343-2025 | Nonconforming Material/Component | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic… |
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 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241078Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · 5 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?
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. 2020, 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/K201214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201214: 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/K201214
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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