510(k) · Cleared
ClearedBwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovirtual USA, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Oct 28, 2011 as substantially equivalent to K932407 (Cadwell Laboratories, Inc., 1994) and 2 other predicates after a 98-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Oct 28, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K932407 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK932407 Cadwell Easy Writer and Easy ReaderCadwell Laboratories, Inc. · 1994
- 1 generation backK062533 Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006
- This deviceK112107 Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932407 | Cadwell Easy Writer and Easy Reader | Cadwell Laboratories, Inc. | 1994 | — |
| −1 | K062533 | Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524 | Neurovirtual USA, Inc. | 2006 | — |
| 0 (this device) | K112107 | Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus | Neurovirtual USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K932407 | Cadwell Easy Writer and Easy ReaderSummary page 1…tial Equivalence: The SWILL is equivalent with the following products: 510(k) Number Model Coinpany K932407 IEasy Write and Easy Reader ICadwell Laboratories, Inc. K(991900 XLTEC PSG-40 Polysomnogra… | 1994 |
| * | K991900 | Xltek Polysomnography Headbox, Model # PSG-40Summary page 1…Model Coinpany K932407 IEasy Write and Easy Reader ICadwell Laboratories, Inc. K(991900 XLTEC PSG-40 Polysomnography Excel Tech Ltd. K(062533 SWII Digital… | 1999 |
| * | K062533 | Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Summary page 1…IEasy Write and Easy Reader ICadwell Laboratories, Inc. K(991900 XLTEC PSG-40 Polysomnography Excel Tech Ltd. K(062533 SWII Digital Neurovirtual USA Inc. Technological Characteristics: The predicate d… | 2006 |
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 17 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K932407.
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?
The BWIII system may be used for electroencephalography (EEG) and sleep recordings (Polysomnography) in research and Clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user.
The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.
The BWIII does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112107: Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112107
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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