510(k) · Cleared
ClearedWavestate Neuromonitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavestate, Inc. · ORT Burst Suppression Detection Software For Electroencephalograph
Cleared on Jun 29, 2010 as substantially equivalent to K021185 (Taugagreining HF, 2002) and 2 other predicates after a 306-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jun 29, 2010
- Review
- 306 days
- Class
- Class II
- Product code
- ORT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K964280 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964280 | DG Nervus | Medelec, Ltd. | 1997 | 1 |
| −1 | K061908 | Nicoletone System V32 Amplifier | Viasys Neuro Care | 2006 | — |
| 0 (this device) | K092625 | Wavestate Neuromonitor | Wavestate, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ORT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021185 | Nervus MonitorSummary page 1…keted Equivalent Device Company Product 510(k)# Taugagreining HF Nervus Monitor K021 185 Viasys NeuroCare, Inc. NicoletOne System V32 K061908 Lifelines Ltd. Lifelines Trac… | 2002 |
| * | K061908 | Nicoletone System V32 AmplifierSummary page 1…510(k)# Taugagreining HF Nervus Monitor K021 185 Viasys NeuroCare, Inc. NicoletOne System V32 K061908 Lifelines Ltd. Lifelines Trackit K010460 DEVICE DESCRIPTION… | 2006 |
| * | K010460 | Lifelines TrackitSummary page 1…K021 185 Viasys NeuroCare, Inc. NicoletOne System V32 K061908 Lifelines Ltd. Lifelines Trackit K010460 DEVICE DESCRIPTION 807.92(a)(4) Wavestate, Inc. has created a new application for the… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 5 other devices also cite its predicate K021185.
How does its category compare?
All ORT devicesORT Burst Suppression Detection Software For Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ORT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · ORT
Too few ORT 510(k)s in any year since 2007 to give a median.
Recalls per year · ORT
No recall names ORT since 2007.
Adverse event reports per year · ORT
1in 2025
MAUDE reports naming product code ORT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (117 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092625: Wavestate Neuromonitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092625
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026