2026-09-16 00:00 Policy & Regulation Regulatory Approval Source language EN

FDA Clears Ceribell EEG Analysis Software Under 510(k)

Summary The US Food and Drug Administration has cleared EEG Analysis Software from Ceribell, a US medical device company, through the 510(k) pathway after finding it substantially equivalent to a device already on the market. The software performs quantitative analysis of EEG signals and is regulated as a Class II device under the Neurology review panel. A 510(k) clearance only requires showing equivalence to an existing product, a lower bar than the premarket approval required for high-risk devices. The FDA record does not describe the software's indications or specific analysis functions.

Why it matters This is a routine 510(k) clearance based on substantial equivalence, not approval of a novel device. The public FDA record lists only classification details and is silent on intended use and performance; what the software under K261712 is cleared to do will depend on Ceribell's own disclosures.

BCIwiki (bciwiki.com) — The US Food and Drug Administration has cleared Ceribell EEG Analysis Software from Ceribell, Inc. under the 510(k) pathway, according to an FDA database record dated September 16, 2026. The clearance, K261712, was a Traditional 510(k) with a finding of Substantially Equivalent.

The FDA classifies the product as Non-Normalizing Quantitative Electroencephalograph Software, a Class II medical device under regulation number 882.1400, reviewed by the Neurology advisory panel.

A 510(k) clearance requires a manufacturer to show that a device is substantially equivalent to one already legally marketed, a lower bar than the premarket approval (PMA) required for high-risk devices. The FDA record does not state the software's indications, analysis functions or performance data.

Compiled by BCIwiki from public sources

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accessdata.fda.gov 2026-09-16

EEG Non-invasive BCI

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