510(k) · Cleared
ClearedWAVi SCAN EEG System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavi Co. · GWQ Full-Montage Standard Electroencephalograph
Cleared on May 6, 2022 as substantially equivalent to K171781 (Evoke Neuroscience, Inc., 2017) and 2 other predicates after a 143-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- May 6, 2022
- Review
- 143 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K873535 (1987). 45 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 6 generations between
- 3 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 2 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 1 generation backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- This deviceK213900 WAVi SCAN EEG System and AccessoriesWavi Co. · 2022
Show all 10 generations
- Root · 10 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 9 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 8 generations backK072014 VitascoreVitascore B.V. · 2007
- 7 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 6 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 5 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 4 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 3 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 2 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 1 generation backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- This deviceK213900 WAVi SCAN EEG System and AccessoriesWavi Co. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −9 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −8 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −7 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −6 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −5 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −4 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −3 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −2 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| −1 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| 0 (this device) | K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K171781 | eVox SystemSummary page 4…Class II Classification Name: Electroencephalograph Predicate Devices: 510(k) Number Trade Name K171781 eVox System Evoke Neuroscience… | 2017 |
| * | K143233 | Mitsar-EEGSummary page 4…200 Valencia Dr. Suite 109 Jacksonville. NC 28546 K143233 Mitsar-EEG Nova Tech EEG… | 2015 |
| * | K141316 | Cognision Eeg/EP SystemSummary page 4…a Tech EEG 8503 E. Keats Avenue Mesa, AZ 85209 K141316 COGNISION™ EEG/EP SYSTEM Neuronetrix Solutions… | 2015 |
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 35 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 45 ancestors have a recall of any class.
- 2 other devices also cite its predicate K171781.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
WAVi SCAN EEG 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213900: WAVi SCAN EEG System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213900
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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