510(k) · Cleared
ClearedExcel Neuro Works
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Tech., Ltd. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Apr 21, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it.
- Decided
- Apr 21, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK980214 Excel Neuro WorksExcel Tech., Ltd. · 1998
- Descendant · cites it directly · 14 of its ownK053386 Xltek EMU40 Eeg Headbox, Model PK1072Excel Tech., Ltd. · 2006
- Descendant · 2 generations on · 12 of its ownK072382 Model I-2000 MonitorInfinite Biomedical Technologies · 2008
- Descendant · 3 generations on · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- Descendant · 4 generations on · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K053386Xltek EMU40 Eeg Headbox, Model PK1072Excel Tech., Ltd. · 2006 · cites it directly14descendants
- K072382Model I-2000 MonitorInfinite Biomedical Technologies · 2008 · 2 generations on12descendants
- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · 3 generations on11descendants
- K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010 · 3 generations on6descendants
- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980214 | Excel Neuro Works | Excel Tech., Ltd. | 1998 | — |
| +1 | K053386 | Xltek EMU40 Eeg Headbox, Model PK1072 | Excel Tech., Ltd. | 2006 | — |
| +2 | K072382 | Model I-2000 Monitor | Infinite Biomedical Technologies | 2008 | — |
| +3 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +3 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| +4 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (18)
See all 183 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?
- Of its descendants, K053386 (Excel Tech., Ltd., 2006) has gone furthest, with 14 descendants of its own.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 NeuroWorks EEG is an clcctroencephalograph which is designed to display the electrical signals of the brain.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980214: Excel Neuro Works.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980214
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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