510(k) · Cleared
ClearedNicoletone System V32 Amplifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Neuro Care · GWQ Full-Montage Standard Electroencephalograph
Cleared on Nov 6, 2006 as substantially equivalent to K964280 (Medelec, Ltd., 1997) and 1 other predicate after a 124-day review. Its family tree reaches back 1 generation to 1997. 19 later devices descend from it.
- Decided
- Nov 6, 2006
- Review
- 124 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964280 (1997). 2 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK964280 DG NervusMedelec, Ltd. · 1997 · Recalled
- This deviceK061908 Nicoletone System V32 AmplifierViasys Neuro Care · 2006
- Descendant · cites it directly · 11 of its ownK143233 Mitsar-EEGMitsar Co., Ltd. · 2015
- Descendant · cites it directly · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K143233Mitsar-EEGMitsar Co., Ltd. · 2015 · cites it directly11descendants
- K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · cites it directly7descendants
- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · 2 generations on6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · 3 generations on3descendants
- K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964280 | DG Nervus | Medelec, Ltd. | 1997 | 1 |
| 0 (this device) | K061908 | Nicoletone System V32 Amplifier | Viasys Neuro Care | 2006 | — |
| +1 | K143233 | Mitsar-EEG | Mitsar Co., Ltd. | 2015 | — |
| +1 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| +2 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +3 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +4 | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K964280 | DG NervusSummary page 1…Electroencephalograph Classification Name: Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class II Predicate Device(s): K964280 DG Nervus K990522 Digital EEG and Sleep Acquisition System with or… | 1997 |
| * | K990522 | Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse…Summary page 1…cation Name: Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class II Predicate Device(s): K964280 DG Nervus K990522 Digital EEG and Sleep Acquisition System with or Without Pulse Oximetery Feature (Warat… | 1999 |
What descends from it? (19)
See all 193 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?
NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SPO2) is available.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061908 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061908: Nicoletone System V32 Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061908
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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