510(k) · Cleared
ClearedNihon Kohden Wireless Input Unit WEE-1200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · GWQ Full-Montage Standard Electroencephalograph
Cleared on Aug 25, 2017 as substantially equivalent to K033475 (Nihon Kohden America, Inc., 2004) and 1 other predicate after a 130-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 25, 2017
- Review
- 130 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944678 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- 3 generations backK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- 2 generations backK080546 Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008
- 1 generation backK113117 Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction…Nihon Kohden America, Inc. · 2012
- This deviceK171124 Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| −3 | 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 | — |
| −1 | K113117 | Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box | Nihon Kohden America, Inc. | 2012 | — |
| 0 (this device) | K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K033475 | Wireless Input Unit, Model Wee-1000A SeriesSummary page 4…(EEG) Primary product GWQ, OLV codes: Regulation numbers: 21 CFR 882.1400 Substantial equivalence claimed to: Nihon Kohden Wireless Input Unit WEE-1000A (K033475) Nihon Kohden EEG-1200A with JE-120A Multi Channel… | 2004 |
| * | K113117 | Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction BoxSummary page 4…1000A (K033475) Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box (K113117) Description: The WEE-1200 Wireless Input Unit is a system that can be used in routine EEG testing, epilepsy monitoring, or PSG… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K033475.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph via wired or wireless communication to display EEG on the electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical personnel in a medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171124: Nihon Kohden Wireless Input Unit WEE-1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171124
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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