# K191868: iCEWav Neuromonitoring Platform

- Pathway: 510(k) (Traditional)
- Applicant: Ice Neurosystems, Inc.
- Decided: Mar 31, 2020 after 263 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- 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: 7 generations back to K875179 (1988). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080217: Component Neuromonitoring System, Moberg Research, Inc. (2008) Summary page 4.
- K151929: Persyst 13 (P13) Eeg Review and Analysis Software, Persyst Development Corporation (2015) Summary page 4.

## Indications for use
The iCEWav Neuromonitoring Platform (iCEWav) is intended to monitor the state of the brain by recording and displaying EEG signals and can also receive and display a variety of vital signs and other measurements from third-party devices. The iCEWav Neuromonitoring Platform is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated. The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition.

Source page: https://510kreport.com/device/K191868
Methodology: https://510kreport.com/methodology