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

Ceribell, Inc. is a medical technology company focused on transforming diagnosis and management of patients with serious neurological conditions. Headquartered in Sunnyvale, California, the company has developed a point-of-care electroencephalography (EEG) platform combining portable hardware with artificial intelligence-powered algorithms for rapid diagnosis and continuous monitoring in acute care settings.

Ceribell has received 13 FDA 510(k) clearances from 13 total submissions since its first clearance in 2017. The company specializes exclusively in Neurology devices, with its most recent clearance in 2026, demonstrating continued active development and regulatory engagement in seizure detection and EEG monitoring technologies.

The Ceribell System is FDA 510(k) cleared for indicating suspected seizure activity and is utilized in intensive care units and emergency departments across the United States. The platform addresses unmet needs in acute care by enabling clinicians to rapidly assess patients with neurological conditions at the point of care.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.

3 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.