Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ceribell, Inc. · Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time
182 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261101Ceribell MonitorCeribell, Inc.2026-06-30890
K260998Ceribell Neurology Review SoftwareCeribell, Inc.2026-06-24900
K260363Ceribell Brain Monitor HeadbandCeribell, Inc.2026-04-03580
K254033Ceribell Instant EEG HeadsetCeribell, Inc.2026-02-09550
K251936Ceribell Delirium Monitor SystemCeribell, Inc.2025-12-081670
K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.2025-11-211430
K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)Ceribell, Inc.2025-10-311820
K241589Ceribell Seizure Detection SoftwareCeribell, Inc.2025-04-093100
K232052Ceribell Instant EEG HeadbandCeribell, Inc.2023-08-08290
K223504Ceribell Status Epilepticus MonitorCeribell, Inc.2023-05-231820
K223086Ceribell Instant EEG HeadcapCeribell, Inc.2023-03-221730
K210805Ceribell Instant EEG HeadbandCeribell, Inc.2021-08-301660
K191301Ceribell Pocket EEG DeviceCeribell, Inc.2019-09-111200
K171459Ceribell Instant EEG HeadbandCeribell, Inc.2017-08-21950
K170363Ceribell Pocket EEG DeviceCeribell, Inc.2017-05-08910

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda