Data / Medical devices / United States / Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc.: FDA-registered device maker in San Diego, CA, United States, 6 510(k) clearances
Tandem Diabetes Care, Inc. is registered with the FDA (registration 3032746481) in San Diego, CA, United States. It lists 2 device types. The FDA files 6 510(k) clearances 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
- 3032746481
- Address
- 5995 Pacific Center Blvd Ste 104, San Diego, CA, United States, 92121
- Owner or operator
- Tandem Diabetes Care, Inc. (10039506)
- Roles
- Manufacturer
- First device listed
- November 23, 2020
- Registered through
- 2027
- Brand names listed
- T:slim X2 Insulin Pump, Tandem Mobi Adhesive Sleeve, Tandem Mobi System, t:slim X2 with Basal-IQ technology
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Manufacturer | 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 | 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 4, 2020 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Alternate Controller Enabled Insulin Infusion Pump
- All makers of Tape And Bandage, Adhesive
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.