510(k) · Cleared
ClearedXltek Trex Model#10309
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 Aug 27, 2004 after an 18-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Aug 27, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK042150 Xltek Trex Model#10309Excel Tech., Ltd. · 2004
- Descendant · cites it directly · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · 2 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · 3 generations on · 1 of its ownK133995 Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK131335 Bwmini Eeg, Bwminihst, Bwmini PSGNeurovirtual USA, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK131266 Trez_HDExcel-Tech Ltd. (Xltek) · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · cites it directly4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 2 generations on3descendants
- K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015 · 3 generations on1descendant
- K131335Bwmini Eeg, Bwminihst, Bwmini PSGNeurovirtual USA, Inc. · 2015 · cites it directly1descendant
- K131266Trez_HDExcel-Tech Ltd. (Xltek) · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042150 | Xltek Trex Model#10309 | Excel Tech., Ltd. | 2004 | — |
| +1 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +2 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +3 | K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | Neurosoft, Ltd. | 2015 | — |
| +1 | K131335 | Bwmini Eeg, Bwminihst, Bwmini PSG | Neurovirtual USA, Inc. | 2015 | — |
| +1 | K131266 | Trez_HD | Excel-Tech Ltd. (Xltek) | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (9)
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?
- Of its descendants, K071782 (Micromed S.P.A., 2008) has gone furthest, with 4 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 XLTEK TREX is intended to be used as an electroencephalograph: acquire, display, store and archive electroencephalographic signals.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042150: Xltek Trex Model#10309.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042150
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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