510(k) · Cleared
ClearedNihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box
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 Mar 22, 2012 as substantially equivalent to K080546 (Nihon Kohden America, Inc., 2008) after a 153-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 22, 2012
- Review
- 153 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944678 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- 2 generations backK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- 1 generation backK080546 Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008
- This deviceK113117 Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction…Nihon Kohden America, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK171124 Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation · 2017
- Descendant · cites it directly · 0 of its ownK131415 Live View Panel (LVP)Neurotronics, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| −2 | K992742 | Neurofax, Model Eeg-1100A | Nihon Kohden America, Inc. | 1999 | — |
| −1 | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A | Nihon Kohden America, Inc. | 2008 | — |
| 0 (this device) | K113117 | Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box | Nihon Kohden America, Inc. | 2012 | — |
| +1 | K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation | 2017 | — |
| +1 | K131415 | Live View Panel (LVP) | Neurotronics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ASummary page 2…+QI-123A Product used with Electroencephalograph EEG-120OA Electroencephalograph EEG-1200 Electroencephalograph EEG-1200A KN4080546 K<080546 K#080546 Intended Use Electrode junction box for EEG… | 2008 |
| † | K040833 | Modification to Ebi Xfix Vision Fixation System | 2004 |
What descends from it? (2)
2 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?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171124 (Nihon Kohden Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K080546.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 EEG- 1200A series Nerurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. This data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113117: Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113117
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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