510(k) · Cleared
Recalled · Class II · 2015DG Nervus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medelec, Ltd. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jan 27, 1997 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 25 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 1997
- Review
- 91 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK964280 DG NervusMedelec, Ltd. · 1997
- Descendant · cites it directly · 19 of its ownK061908 Nicoletone System V32 AmplifierViasys Neuro Care · 2006
- Descendant · 2 generations on · 11 of its ownK143233 Mitsar-EEGMitsar Co., Ltd. · 2015
- Descendant · 2 generations on · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K061908Nicoletone System V32 AmplifierViasys Neuro Care · 2006 · cites it directly19descendants
- K143233Mitsar-EEGMitsar Co., Ltd. · 2015 · 2 generations on11descendants
- K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · 2 generations on7descendants
- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · 3 generations on6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964280 | DG Nervus | Medelec, Ltd. | 1997 | — |
| +1 | K061908 | Nicoletone System V32 Amplifier | Viasys Neuro Care | 2006 | — |
| +2 | K143233 | Mitsar-EEG | Mitsar Co., Ltd. | 2015 | — |
| +2 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| +3 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +4 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (25)
See all 254 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2015 | Class II | Z-0117-2016 | Software change control | When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061908 (Viasys Neuro Care, 2006) has gone furthest, with 19 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 | — |
https://510kreport.com/device/K964280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964280: DG Nervus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964280
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026