510(k) · Cleared
ClearedNihon Kohden Electroencephalograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on May 22, 1995 after a 242-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- May 22, 1995
- Review
- 242 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- Descendant · cites it directly · 18 of its ownK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- Descendant · 2 generations on · 11 of its ownK080546 Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK073491 Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008
- Descendant · 4 generations on · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K992742Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999 · cites it directly18descendants
- K080546Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008 · 2 generations on11descendants
- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · 3 generations on6descendants
- K073491Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008 · 2 generations on5descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| +1 | K992742 | Neurofax, Model Eeg-1100A | Nihon Kohden America, Inc. | 1999 | — |
| +2 | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A | Nihon Kohden America, Inc. | 2008 | — |
| +3 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +2 | K073491 | Eeg-1100A Switch Box | Nihon Kohden America, Inc. | 2008 | — |
| +4 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2025 | 3 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992742 | Neurofax, Model Eeg-1100A | 1999 | 18 |
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, K992742 (Nihon Kohden America, Inc., 1999) has gone furthest, with 18 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/K944678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944678: Nihon Kohden Electroencephalograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944678
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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