510(k) · Cleared
ClearedBwmini Eeg, Bwminihst, Bwmini PSG
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 Feb 3, 2015 as substantially equivalent to K042150 (Excel Tech., Ltd., 2004) and 1 other predicate after a 635-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 3, 2015
- Review
- 635 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946094 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K191492Maxxi Position SensorNeurovirtual USA, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946094 | Cadwell Easy Ambulatory Eeg | Cadwell Laboratories, Inc. | 1995 | — |
| 0 (this device) | K131335 | Bwmini Eeg, Bwminihst, Bwmini PSG | Neurovirtual USA, Inc. | 2015 | — |
| +1 | K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K042150 | Xltek Trex Model#10309Summary page 4…2.1400 G) Substantial Equivalence: The BWMini is equivalent with the following products: 510(k) Number Model Company K042150 XLTEK Trex EXCEL TECH. LTD. CADWELL EASY AMBULATORY CADWELL LABOR… | 2004 |
| * | K946094 | Cadwell Easy Ambulatory EegSummary page 4…Company K042150 XLTEK Trex EXCEL TECH. LTD. CADWELL EASY AMBULATORY CADWELL LABORATORIES, K946094 EEG INC. Page 1 of 5 === Page 5 ==… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191492 | Maxxi Position Sensor | 2020 | 0 |
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?
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.
The BWMini 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131335: Bwmini Eeg, Bwminihst, Bwmini PSG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131335
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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