Tandem Diabetes Care, Inc.
FDA 510(k) & PMA Approved Devices — 20 products
Total Devices20
Categories6
Latest FDA decision2026-04-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260429 | Control-IQ+ technology | QJI | 2026-04-24 | View |
| 510(k) | K253074 | Tandem Mobi insulin pump with interoperable technology | QFG | 2025-11-06 | View |
| 510(k) | K250792 | t:slim X2 insulin pump with interoperable technology | QFG | 2025-09-24 | View |
| 510(k) | K250798 | Control-IQ+ technology | QJI | 2025-05-21 | View |
| 510(k) | K243823 | Control-IQ+ technology | QJI | 2025-02-24 | View |
| 510(k) | K241078 | Tandem Mobi Insulin Pump with interoperable technology | QFG | 2024-07-26 | View |
| 510(k) | K240309 | Tandem Mobi insulin pump with interoperable technology | QFG | 2024-03-21 | View |
| 510(k) | K232382 | Control-IQ Technology | QJI | 2023-11-03 | View |
| 510(k) | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | 2023-11-03 | View |
| 510(k) | K233044 | Tandem Mobi insulin pump with interoperable technology | QFG | 2023-10-05 | View |
| 510(k) | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | QFG | 2023-07-10 | View |
| 510(k) | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | QFG | 2022-02-15 | View |
| 510(k) | K200467 | Control-IQ Technology | QJI | 2020-06-16 | View |
| 510(k) | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | 2020-06-04 | View |
| 510(k) | K193483 | Basal-IQ Technology | QJS | 2020-02-28 | View |
| PMA | P140015 | Pump, infusion, insulin, to be used with invasive glucose sensor | OYC | 2019-12-19 | View |
| PMA | P180008 | Automated insulin dosing , threshold suspend | OZO | 2019-12-19 | View |
| 510(k) | K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | LZG | 2016-10-25 | View |
| 510(k) | K160056 | t:slim Insulin Delivery System | LZG | 2016-07-25 | View |
| 510(k) | K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | LZG | 2016-07-13 | View |
No matching devices.
Related Clinical Trials
NCT05014789Control-IQ Technology 2.0 Adult and Adolescent Feasibility StudyCOMPLETEDNCT05785832A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 DiabetesCOMPLETEDNCT07325461Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 DiabetesCOMPLETEDNCT06024928Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 DiabetesCOMPLETED