510(k) · Cleared
ClearedXltek EMU40 Eeg Headbox, Model PK1072
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, 2006 as substantially equivalent to K980214 (Excel Tech., Ltd., 1998) after a 137-day review. Its family tree reaches back 1 generation to 1998. 14 later devices descend from it.
- Decided
- Apr 21, 2006
- Review
- 137 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980214 (1998). 14 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980214 Excel Neuro WorksExcel Tech., Ltd. · 1998
- This deviceK053386 Xltek EMU40 Eeg Headbox, Model PK1072Excel Tech., Ltd. · 2006
- Descendant · cites it directly · 12 of its ownK072382 Model I-2000 MonitorInfinite Biomedical Technologies · 2008
- Descendant · 2 generations on · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K072382Model I-2000 MonitorInfinite Biomedical Technologies · 2008 · cites it directly12descendants
- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · 2 generations on11descendants
- K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010 · 2 generations on6descendants
- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · 3 generations on5descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980214 | Excel Neuro Works | Excel Tech., Ltd. | 1998 | — |
| 0 (this device) | K053386 | Xltek EMU40 Eeg Headbox, Model PK1072 | Excel Tech., Ltd. | 2006 | — |
| +1 | K072382 | Model I-2000 Monitor | Infinite Biomedical Technologies | 2008 | — |
| +2 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +2 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| +3 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| +3 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K980214 | Excel Neuro Works Our reading of the summary gave “K980214}.” beside “510(k)”; FDA’s K980214 is the only number that fits it and carries the summary’s name for the device. Summary page 3…XLTEK EMU40 EEG Headbox Indications for Use: The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software (FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signa… | 1998 |
What descends from it? (14)
See all 142 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?
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 EMU40 Headbox is an electroencephalograph that works in conjunction with
XLTEK NeuroWorks software (FDA 510(k) #K980214}.
The EMU40 Headbox is used to acquire, digitize, store and transmit physiological
signals (such as EEG, pulse and oximetry signals) for EEG studies in research and
clinical environments.
The EMU40 Headbox requires competent user input, and its output must be reviewed
and interpreted by trained medical professionals who will exercise professional
judgment in using this information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053386: Xltek EMU40 Eeg Headbox, Model PK1072.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053386
Report an extraction error
Are you the manufacturer?
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