510(k) · Cleared
ClearedEMU128S, Model EX-NW-128S
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 Mar 12, 2004 after a 28-day review. The FDA summary names its predicate without a number. 1 of the 32 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.
- Decided
- Mar 12, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 4 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- This deviceK040360 EMU128S, Model EX-NW-128SExcel Tech., Ltd. · 2004
- Descendant · cites it directly · 23 of its ownK072964 Nicolet Cortical StimulatorCardinal Health, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 13 of its ownK110410 MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011
- Descendant · 3 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 2 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K171581 Neuro Omega System2 generations on · 2017
Most influential descendants
Showing 5 of 31 · See all- K072964Nicolet Cortical StimulatorCardinal Health, Inc. · 2008 · cites it directly23descendants
- K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011 · 2 generations on13descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 3 generations on9descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 2 generations on7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040360 | EMU128S, Model EX-NW-128S | Excel Tech., Ltd. | 2004 | — |
| +1 | K072964 | Nicolet Cortical Stimulator | Cardinal Health, Inc. | 2008 | 3 |
| +2 | K110410 | MS-120BK Electric Stimulator (Extension Unit) | Nihon Kohden Corp. | 2011 | — |
| +3 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +2 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +3 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 1 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | — | XLTEK 128 Channel EEG Headbox Named without a submission number |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K171581Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K072964 (Cardinal Health, Inc., 2008) has gone furthest, with 23 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 EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.
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/K040360 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040360: EMU128S, Model EX-NW-128S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040360
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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