Company ยท US
Tandem Diabetes Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (1 in 12 months)
15recalls (3 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 20 |
| LZG | Pump, Infusion, Insulin | 8 |
| QJI | Interoperable Automated Glycemic Controller | 6 |
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | 3 |
| FPA | Set, Administration, Intravascular | 1 |
| OUG | Medical Device Data System | 1 |
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 1 |
| QJS | Interoperable Automated Glycemic Controller, Insulin Suspend | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2026 | K260429 | Control-IQ+ technology Tandem Diabetes Care, Inc. | QJI |
| Nov 6, 2025 | K253074 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Sep 24, 2025 | K250792 | t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Aug 6, 2025 | K251854 | SteadiSet infusion set Tandem Diabetes Care | FPA |
| May 21, 2025 | K250798 | Control-IQ+ technology Tandem Diabetes Care, Inc. | QJI |
| Feb 24, 2025 | K243823 | Control-IQ+ technology Tandem Diabetes Care, Inc. | QJI |
| Jul 26, 2024 | K241078 | Tandem Mobi Insulin Pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Mar 21, 2024 | K240309 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Nov 3, 2023 | K232382 | Control-IQ Technology Tandem Diabetes Care, Inc. | QJI |
| Nov 3, 2023 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. | QFG |
| Oct 5, 2023 | K233044 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Jul 10, 2023 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. | QFG |
| Feb 15, 2022 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) Tandem Diabetes Care, Inc. | QFG |
| Jun 16, 2020 | K200467 | Control-IQ Technology Tandem Diabetes Care, Inc. | QJI |
| Jun 4, 2020 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. | QFG |
| Feb 28, 2020 | K193483 | Basal-IQ Technology Tandem Diabetes Care, Inc. | QJS |
| Dec 13, 2019 | DEN190034 | Control-IQ Technology Tandem Diabetes Care, Inc. | QJI |
| Feb 14, 2019 | DEN180058 | t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Oct 25, 2016 | K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. | LZG |
| Jul 25, 2016 | K160056 | t:slim Insulin Delivery System Tandem Diabetes Care, Inc. | LZG |
| Jul 13, 2016 | K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. | LZG |
| Jan 9, 2015 | K143189 | t:flex Insulin Delivery System Tandem Diabetes Care, Inc. | LZG |
| Oct 31, 2014 | K141758 | T:SLIM INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc. | LZG |
| Mar 24, 2014 | K133593 | T:SLIM INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc. | LZG |
| Feb 22, 2013 | K122361 | T:CONNECT DATA MANAGEMENT SYSTEM Tandem Diabetes Care, Inc. | OUG |
| Nov 9, 2011 | K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc. | LZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018 Open, Classified |
QFG | K223213 K233044 +3 |
| Sep 29, 2026 | Tandem Diabetes Care, Inc. Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 0038915247 Open, Classified |
QFG | K201214 K203234 +1 |
| Mar 25, 2026 | Tandem Diabetes Care, Inc. Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, Open, Classified |
QFG | K232380 K232382 +3 |
| Nov 5, 2025 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump:
Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism Open, Classified |
QFG | K223213 K233044 +2 |
| Oct 23, 2025 | Tandem Diabetes Care, Inc. t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor;
Tandem Mobi insulin pump with Interop Open, Classified |
QFG | K201214 K203234 +2 |
| Sep 24, 2025 | Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) Open, Classified |
QFG | K232380 |
| Aug 27, 2025 | Tandem Diabetes Care, Inc. Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911;
t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;
t: slim X2, Basal-IQ, mg/dl, REF: 1004219;
Pump, t: Open, Classified |
QFG | K193483 K201214 |
| Apr 11, 2025 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump with Interoperable Technology Open, Classified |
QFG | K241078 |
| Apr 11, 2025 | Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology Open, Classified |
QFG | K232380 |
| May 6, 2024 | Tandem Diabetes Care, Inc. t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology Open, Classified |
QFG | K203234 |
| Sep 26, 2022 | Tandem Diabetes Care Inc t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology Open, Classified |
PQF | None listed |
| Sep 26, 2022 | Tandem Diabetes Care Inc t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology Open, Classified |
PQF | None listed |
| Jun 10, 2022 | Tandem Diabetes Care Inc t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology Open, Classified |
PQF | None listed |
| Apr 23, 2018 | Tandem Diabetes Care Inc t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. Open, Classified |
OYC | None listed |
| Feb 10, 2014 | Tandem Diabetes Care Inc T:slim Insulin Delivery System
Insulin Infusion Pump Terminated |
LZG | K111210 |