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510(k) K251881

HippoMind (v1.0) by Hippoclinic — Product Code OLT

K251881 is an FDA 510(k) premarket notification submitted by Hippoclinic for the device "HippoMind (v1.0)". The FDA issued a decision of Substantially Equivalent on December 3, 2025. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2025
Date Received
June 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

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  • K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (November 30, 2022)
  • K213299 — Wireless EEG System (May 11, 2022)
  • K191322 — E-EEGX, N-EEGX (January 22, 2020)
  • K192572 — CNS Envision (December 17, 2019)
  • K190760 — Cadwell Bolt Software (November 23, 2019)
  • K143487 — Lifelines iEEG (August 21, 2015)
  • K142834 — DiscoverEEG System, Model DE-401 (June 23, 2015)

FDA data resources