# K202621: NeuroSENSE Monitoring System, Model NS-901

- Pathway: 510(k) (Traditional)
- Applicant: Neurowave Systems, Inc.
- Decided: Aug 5, 2021 after 329 days
- Product code: OLW (Index-Generating 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 K963644 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072286: Bis Eeg Vista Monitor System and Bisx, Aspect Medical Systems, Inc. (2007) Summary page 4.

## Indications for use
The NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals. The WAVens Index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics. The anesthetics include inhaled anesthetics and propofol in combination with opioids. The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.

Source page: https://510kreport.com/device/K202621
Methodology: https://510kreport.com/methodology