Cleared Traditional

HippoMind (v1.0)

K251881 · Hippoclinic · Neurology

Dec 2025

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K251881 is an FDA 510(k) clearance for the HippoMind (v1.0), a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Hippoclinic (Mountain View, US). The FDA issued a Cleared decision on December 3, 2025, 168 days after receiving the submission on June 18, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K251881 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2025
Decision Date	December 03, 2025
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.