510(k) · Cleared
ClearedeVox System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evoke Neuroscience, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Dec 13, 2017 as substantially equivalent to K143233 (Mitsar Co., Ltd., 2015) and 2 other predicates after a 181-day review. Its family tree reaches back 9 generations to 1987. 6 later devices descend from it.
- Decided
- Dec 13, 2017
- Review
- 181 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K873535 (1987). 44 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 5 generations between
- 3 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 2 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 1 generation backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- This deviceK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- Descendant · 2 generations on · 0 of its ownK253767 UB ERP SystemUniversal Brain · 2026
- Descendant · cites it directly · 0 of its ownK240420 NeuroField Analysis SuiteNeurofield, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 8 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 7 generations backK072014 VitascoreVitascore B.V. · 2007
- 6 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 5 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 4 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 3 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 2 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 1 generation backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- This deviceK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192753NeuralScan SystemMedeia, Inc. · 2020 · cites it directly3descendants
- K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023 · 2 generations on1descendant
- K253767UB ERP SystemUniversal Brain · 2026 · 2 generations on0descendants
- K240420NeuroField Analysis SuiteNeurofield, Inc. · 2024 · cites it directly0descendants
- K221959Q21Neurofield, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −8 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −7 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −6 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −5 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −4 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −2 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| 0 (this device) | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +1 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +2 | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
| +2 | K253767 | UB ERP System | Universal Brain | 2026 | — |
| +1 | K240420 | NeuroField Analysis Suite | Neurofield, Inc. | 2024 | — |
| +2 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K143233 | Mitsar-EEGSummary page 5…ogy III. PREDICATE DEVICES Legally Marketed Device(s) 510(k) # Clearance Date Mitsar-EEG K143233 8-13-2015 COGNISION EEG K141316 2-13-2015 Nicolet EDX… | 2015 |
| * | K141316 | Cognision Eeg/EP SystemSummary page 5…510(k) # Clearance Date Mitsar-EEG K143233 8-13-2015 COGNISION EEG K141316 2-13-2015 Nicolet EDX System K112052 3-15-2012 IV. DEVICE DESCRIP… | 2015 |
| * | K112052 | Carefusion Nicolet EdxSummary page 5…K143233 8-13-2015 COGNISION EEG K141316 2-13-2015 Nicolet EDX System K112052 3-15-2012 IV. DEVICE DESCRIPTION The eVox System is intended for the acquisition, display, and storage,… | 2012 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 44 ancestors have a recall of any class.
- Of its descendants, K192753 (Medeia, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K143233.
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 eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient’s brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171781: eVox System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171781
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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