510(k) · Cleared
ClearedPE-210AK Switch Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corp. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jul 29, 2011 as substantially equivalent to K040360 (Excel Tech., Ltd., 2004) after a 170-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jul 29, 2011
- Review
- 170 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040360 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040360 EMU128S, Model EX-NW-128SExcel Tech., Ltd. · 2004
- This deviceK110376 PE-210AK Switch BoxNihon Kohden Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040360 | EMU128S, Model EX-NW-128S | Excel Tech., Ltd. | 2004 | — |
| 0 (this device) | K110376 | PE-210AK Switch Box | Nihon Kohden Corp. | 2011 | — |
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 |
|---|---|---|---|
| * | K040360 | EMU128S, Model EX-NW-128SSummary page 1…GWQ. " The legally marketed equivalence: The predicate device is the Excel Tech EMU 128s Switch Matrix commercial distribution March 12, 2004 cleared under 510k # K040360 " A description of the device: The PE-210 A Switch Box is an optional accessory for the EEG-1200A device cleared un… | 2004 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K040360.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
EEG- 1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for BEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
The PE-21OAK Switch Box is an optional accessory for the EEG-1200A device. It is used with the BEG- 1200A to switch between EEG recording and conical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures.
The device is intended for use within a hospital or medical facility under direct supervision of a medical professional
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110376: PE-210AK Switch Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110376
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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