# K221563: Neurosteer EEG Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Neurosteer, Inc.
- Decided: Oct 24, 2022 after 146 days
- Product code: OMC (Reduced- 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: 2 generations back to K830295 (1983). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170363: Ceribell Pocket EEG Device, Ceribell, Inc. (2017) Summary page 4.
- K171459: Ceribell Instant EEG Headband, Ceribell, Inc. (2017) Summary page 4.

## Most influential descendants
- K232779: Quex ED; Quex S (2024), 0 descendants of its own
- K240593: VEEGix EEG System (2024), 0 descendants of its own

## Indications for use
The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.

Source page: https://510kreport.com/device/K221563
Methodology: https://510kreport.com/methodology