Tandem Diabetes Care Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 12 (6 Class I)
- 510(k) Clearances
- 25
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0427-2026 | Class I | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion p | October 6, 2025 |
| Z-0232-2026 | Class II | t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, | August 5, 2025 |
| Z-2343-2025 | Class I | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS | July 21, 2025 |
| Z-2621-2025 | Class II | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) | July 3, 2025 |
| Z-1520-2025 | Class I | Tandem Mobi Insulin Pump with Interoperable Technology | February 27, 2025 |
| Z-1519-2025 | Class I | t:slim X2 Insulin Pump with Interoperable Technology | February 27, 2025 |
| Z-1609-2024 | Class I | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology | March 5, 2024 |
| Z-1811-2022 | Class II | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ | May 24, 2022 |
| Z-1812-2022 | Class II | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ | May 24, 2022 |
| Z-1258-2022 | Class II | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technolog | September 10, 2020 |
| Z-2471-2018 | Class II | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 0 | April 23, 2018 |
| Z-0827-2014 | Class I | T:slim Insulin Delivery System Insulin Infusion Pump | January 10, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253074 | Tandem Mobi insulin pump with interoperable technology | November 6, 2025 |
| K250792 | t:slim X2 insulin pump with interoperable technology | September 24, 2025 |
| K251854 | SteadiSet infusion set | August 6, 2025 |
| K250798 | Control-IQ+ technology | May 21, 2025 |
| K243823 | Control-IQ+ technology | February 24, 2025 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | July 26, 2024 |
| K240309 | Tandem Mobi insulin pump with interoperable technology | March 21, 2024 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | November 3, 2023 |
| K232382 | Control-IQ Technology | November 3, 2023 |
| K233044 | Tandem Mobi insulin pump with interoperable technology | October 5, 2023 |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | July 10, 2023 |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | February 15, 2022 |
| K200467 | Control-IQ Technology | June 16, 2020 |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | June 4, 2020 |
| K193483 | Basal-IQ Technology | February 28, 2020 |
| DEN190034 | Control-IQ Technology | December 13, 2019 |
| DEN180058 | t:slim X2 insulin pump with interoperable technology | February 14, 2019 |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | October 25, 2016 |
| K160056 | t:slim Insulin Delivery System | July 25, 2016 |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | July 13, 2016 |