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

Glooko, Inc. is a digital health company specializing in diabetes management and remote patient monitoring. Based in Palo Alto, California, the company develops integrated platforms that connect patients, healthcare providers, and medical devices to streamline diabetes data collection and clinical oversight.

The company has received 5 FDA 510(k) clearances from 5 total submissions since its first clearance in 2012. Chemistry devices represent the dominant category, accounting for approximately 80% of submissions. The most recent clearance was issued in 2026, confirming active regulatory engagement and ongoing product development.

Glooko's cleared devices include cloud-based systems for insulin dosing, glucose monitoring, and diabetes data logging. The company also offers mobile applications and remote monitoring platforms designed for Type 1 and Type 2 diabetes management, as well as gestational diabetes surveillance. These solutions facilitate real-time data sharing between patients and clinical teams.

Explore the complete list of device names, product codes, and clearance dates in the database to review Glooko's full regulatory history and current cleared portfolio.