# K092625: Wavestate Neuromonitor

- Pathway: 510(k) (Traditional)
- Applicant: Wavestate, Inc.
- Decided: Jun 29, 2010 after 306 days
- Product code: ORT (Burst Suppression Detection Software For 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 K964280 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021185: Nervus Monitor, Taugagreining HF (2002) Summary page 1.
- K061908: Nicoletone System V32 Amplifier, Viasys Neuro Care (2006) Summary page 1.
- K010460: Lifelines Trackit, Lifelines, Ltd. (2001) Summary page 1.

## Indications for use
The Wavestate Neuromonitor System is intended to collect, record, and store Lip to 24 channels of adult EEG data for up to 24 hours. The System also can perform a post review of adult BEG data and identify burst suppression pattern in the stored BEG. The device displays the mean interburst interval reviewed up to that time point and the probability that the displayed value is within +1-2 seconds of the mean of the interburst intervals for the entire dataset for that patient. The Wavestate Neuromnonitor System does not provide any diagnostic conclusion about the patient's condition to the user. The Wavestate Neuromonitor is to be used under the guidance and interpretation of a licensed medical practitioner.

Source page: https://510kreport.com/device/K092625
Methodology: https://510kreport.com/methodology