Dexcom, Inc. - FDA 510(k) Cleared Devices

Dexcom, Inc. is a medical device company headquartered in San Diego, US. The company specializes in continuous glucose monitoring systems and related chemistry devices.

Dexcom has received 21 FDA 510(k) clearances from 24 total submissions since its first clearance in 2014. The company's regulatory portfolio is dominated by chemistry devices, which account for 92% of submissions. The latest clearance was granted in 2026, reflecting active ongoing development and regulatory engagement.

The company's cleared device portfolio centers on continuous glucose monitoring technology. Recent FDA 510(k) clearances include iterations of the Dexcom G7 Continuous Glucose Monitoring System, the Dexcom G6, Dexcom Smart Basal, and the Stelo Glucose Biosensor System. These devices support real-time glucose data access, customizable alerts, and integration with smartphones and compatible insulin pumps.

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

3 devices have linked clinical trials registered on ClinicalTrials.gov.