Tandem Diabetes Care, Inc. - FDA 510(k) Cleared Devices

Tandem Diabetes Care, Inc. is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for insulin infusion therapy and diabetes treatment.

The company has received 23 FDA 510(k) clearances from 25 total submissions since its first clearance in 2011. Chemistry devices represent the dominant category of its regulatory portfolio. The latest FDA 510(k) clearance was granted in 2025, reflecting continued active development and regulatory engagement.

Recent cleared devices include the Tandem Mobi insulin pump with interoperable technology and the t:slim X2 insulin pump with interoperable technology, along with Control-IQ+ technology platforms. These products demonstrate the company's focus on advanced insulin delivery systems and automated glucose management solutions.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.

4 devices have linked clinical trials registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.