# K251881: HippoMind (v1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Hippoclinic
- Decided: Dec 3, 2025 after 168 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K875179 (1988). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200878: Natus NeuroWorks, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (2020) Summary page 5.
- K172490: eUnity, Client Outlook, Inc. (2018) Summary page 5.
- K030737: Omega Whole-Cortex MFG System, Models Omega 151, Omega 275, Ctf Systems (2001), Inc. (2003) Summary page 5.

## Indications for use
HippoMind is a software application that displays neuroimaging and neurosignaling data for review by a health care provider. It provides simple tools for analysis of both medical images and EEG/MEG data. It also allows for storage and transfer of data, and association of data with electronic health records. It is intended for use by qualified health care professionals.

Source page: https://510kreport.com/device/K251881
Methodology: https://510kreport.com/methodology