510(k) · Cleared
ClearedNeuronaute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioserenity · GWQ Full-Montage Standard Electroencephalograph
Cleared on Dec 26, 2017 as substantially equivalent to K131383 (Advanced Brain Monitoring, Inc., 2013) and 1 other predicate after a 343-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Dec 26, 2017
- Review
- 343 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K873535 (1987). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 7 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 6 generations backK072014 VitascoreVitascore B.V. · 2007
- 5 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 4 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 3 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 2 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 1 generation backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- This deviceK170138 NeuronauteBioserenity · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −7 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −6 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −5 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| 0 (this device) | K170138 | Neuronaute | Bioserenity | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 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 GWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareSummary page 4…es System Rythmlink Disc electrodes Manufacturer Advanced Brain Monitoring Rhythmlink International, LLC 510(k) Number K131383 K061148 Regulatory Class II II Regulation Number 882.14… | 2013 |
| * | K061148 | Rhythmlink Disc ElectrodesSummary page 4…ink Disc electrodes Manufacturer Advanced Brain Monitoring Rhythmlink International, LLC 510(k) Number K131383 K061148 Regulatory Class II II Regulation Number 882.1400 882.13… | 2006 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 24 ancestors has a recall of any class.
- 4 other devices also cite its predicate K131383.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.
It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.
The Neuronaute requires operation by a trained healthcare professional.
The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170138: Neuronaute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170138
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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