Data / Medical devices / United States / Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc.: FDA-registered device maker in San Diego, CA, United States, 11 510(k) clearances and 1 PMA approval
Tandem Diabetes Care, Inc. is registered with the FDA (registration 3016540876) in San Diego, CA, United States. It lists 8 device types. The FDA files 11 510(k) clearances and 1 PMA approval 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
- 3016540876
- Address
- 6495 Marindustry Place, San Diego, CA, United States, 92121
- Owner or operator
- Tandem Diabetes Care, Inc. (10039506)
- Roles
- Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler
- First device listed
- January 16, 2012
- Registered through
- 2027
- Brand names listed
- Control-IQ Technology, T:slim X2 Insulin Pump, Tandem Mobi Adhesive Sleeve, Tandem Mobi System, t:slim X2, t:slim X2 Insulin Pump, t:slim X2 Insulin Pump with Basal-IQ, t:slim X2 with Basal-IQ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Automated Insulin Dosing , Threshold Suspend | OZO | 3 | Repackager or relabeler | accessdata.fda.gov |
| Calculator, Drug Dose | NDC | 2 | Manufacturer for export | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller | QJI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller, Insulin Suspend | QJS | 2 | Manufacturer for export | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | 3 | Repackager or relabeler | 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 |
| 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 |
| 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 |
Compare with other makers
- All makers of Interoperable Automated Glycemic Controller
- All makers of Alternate Controller Enabled Insulin Infusion Pump
- All makers of Sensor, Glucose, Invasive, Non-Adjunctive
- All makers of Automated Insulin Dosing , Threshold Suspend
- 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.