2025-12-03 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Clears Hippoclinic HippoMind EEG Software

Summary The FDA cleared Hippoclinic's HippoMind, version 1.0, on December 3, 2025, finding it substantially equivalent under submission number K251881 through the traditional 510(k) pathway. The agency classifies it as Non-Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Unlike normalizing tools, non-normalizing quantitative EEG software reports an individual's own EEG metrics without reference to a population database.

Why it matters With no normative database behind it, the software makes no population comparison and leaves the interpretive work with the reading clinician, which is the practical line between the two quantitative EEG categories the FDA recognizes.

BCIwiki (bciwiki.com) — Hippoclinic received an FDA 510(k) decision of Substantially Equivalent for HippoMind (v1.0) on December 3, 2025, under submission number K251881. The submission followed the Traditional 510(k) clearance pathway.

FDA lists the product under the device classification name Non-Normalizing Quantitative Electroencephalograph Software. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Unlike normalizing tools, non-normalizing quantitative EEG software reports an individual's own EEG metrics without reference to a population database.

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accessdata.fda.gov 2025-12-03

EEG Non-invasive BCI United States

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