Data / Medical devices / United States / Ceribell, Inc.

Ceribell, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 13 510(k) clearances

Name: Ceribell, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ceribell, Inc. is registered with the FDA (registration 3013671918) in Sunnyvale, CA, United States. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ceribell, Inc.

FDA registration number: 3013671918
Address: 360 N Pastoria Ave, Sunnyvale, CA, United States, 94085
Owner or operator: Ceribell, Inc. (10055114)
Roles: Manufacturer
First device listed: June 8, 2017
Registered through: 2026
Brand names listed: Ceribell Brain Monitor Headband, Ceribell Delirium Monitor System, Ceribell EEG Headband, Ceribell EEG Headcap, Ceribell EEG Recorder, Ceribell EEG Recorder with Clarity, Ceribell Infant Seizure Detection Software (Clarity), Ceribell Instant EEG Headcap and more

Devices it lists

Device	Product code	Class	Role	Source
Automatic Event Detection Software For Full-Montage Electroencephalograph	OMB	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid	NCG	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	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
April 3, 2026	K260363	Ceribell Brain Monitor Headband	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
February 9, 2026	K254033	Ceribell Instant EEG Headset	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
December 8, 2025	K251936	Ceribell Delirium Monitor System	NCG	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
November 21, 2025	K252070	Ceribell Infant Seizure Detection Software	OMB	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
October 31, 2025	K251381	Ceribell Instant EEG Headcap (Small: C251, Medium: C252)	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
April 9, 2025	K241589	Ceribell Seizure Detection Software	OMB	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
August 8, 2023	K232052	Ceribell Instant EEG Headband	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
May 23, 2023	K223504	Ceribell Status Epilepticus Monitor	OMB	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
March 22, 2023	K223086	Ceribell Instant EEG Headcap	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
August 30, 2021	K210805	Ceribell Instant EEG Headband	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
September 11, 2019	K191301	Ceribell Pocket EEG Device	OMB	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
August 21, 2017	K171459	Ceribell Instant EEG Headband	GXY	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov
May 8, 2017	K170363	Ceribell Pocket EEG Device	OMC	Substantially Equivalent	Ceribell, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 3, 2026. 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.