Data / Medical devices / United States / Tandem Diabetes Care, INC.
Tandem Diabetes Care, INC.: FDA-registered device maker in San Diego, CA, United States, 17 510(k) clearances and 2 PMA approvals
Tandem Diabetes Care, INC. is registered with the FDA (registration 3013756811) in San Diego, CA, United States. It lists 11 device types. The FDA files 17 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 26, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013756811
- Address
- 10151 Barnes Canyon Road 10151 Barnes Canyon Road, San Diego, CA, United States, 92121
- Owner or operator
- Tandem Diabetes Care, Inc. (10039506)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 16, 2012
- Registered through
- 2027
- Brand names listed
- Control-IQ Technology, T:slim X2 Insulin Pump, Tandem Device Updater, Tandem Mobi Adhesive Sleeve, Tandem Mobi System, t:flex Insulin Delivery System, t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, t:slim G4 System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Automated Insulin Dosing , Threshold Suspend | OZO | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Calculator, Drug Dose | NDC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller | QJI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller, Insulin Suspend | QJS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | OYC | 3 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sensor, Glucose, Invasive | MDS | 3 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | 3 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2024 | K241078 | Tandem Mobi Insulin Pump with interoperable technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| March 21, 2024 | K240309 | Tandem Mobi insulin pump with interoperable technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| November 3, 2023 | K232382 | Control-IQ Technology | QJI | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| November 3, 2023 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| July 10, 2023 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| February 15, 2022 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| June 16, 2020 | K200467 | Control-IQ Technology | QJI | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| June 4, 2020 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| February 28, 2020 | K193483 | Basal-IQ Technology | QJS | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| December 13, 2019 | DEN190034 | Control-IQ Technology | QJI | Unknown | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| February 14, 2019 | DEN180058 | t:slim X2 insulin pump with interoperable technology | QFG | Unknown | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| October 25, 2016 | K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | LZG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| July 25, 2016 | K160056 | t:slim Insulin Delivery System | LZG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| January 9, 2015 | K143189 | t:flex Insulin Delivery System | LZG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| October 31, 2014 | K141758 | T:SLIM INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| March 24, 2014 | K133593 | T:SLIM INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| November 9, 2011 | K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 21, 2018 | P180008 | t:slim X2 Insulin Pump with Basal-IQ Technology | OZO | 6 | December 19, 2019 | accessdata.fda.gov |
| September 8, 2015 | P140015 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | OYC | 29 | December 19, 2019 | accessdata.fda.gov |
Compare with other makers
- All makers of Interoperable Automated Glycemic Controller
- All makers of Alternate Controller Enabled Insulin Infusion Pump
- All makers of Accessories, Pump, Infusion
- All makers of Pump, Infusion, Insulin
- All makers of Interoperable Automated Glycemic Controller, Insulin Suspend
- All makers of Calculator, Drug Dose
Updated July 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.