510(k) · Cleared
ClearedE*Net Neuromonitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physiometrix, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Oct 19, 1993 after a 285-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 39 later devices descend from it.
- Decided
- Oct 19, 1993
- Review
- 285 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 6 citing it directly.
- This deviceK930080 E*Net Neuromonitoring SystemPhysiometrix, Inc. · 1993
- Descendant · cites it directly · 24 of its ownK960732 Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500Physiometrix, Inc. · 1996
- Descendant · 2 generations on · 23 of its ownK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · 3 generations on · 15 of its ownK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- Descendant · 3 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K960732Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500Physiometrix, Inc. · 1996 · cites it directly24descendants
- K033010BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · 2 generations on23descendants
- K071449BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007 · 3 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 3 generations on14descendants
- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930080 | E*Net Neuromonitoring System | Physiometrix, Inc. | 1993 | — |
| +1 | K960732 | Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500 | Physiometrix, Inc. | 1996 | — |
| +2 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +3 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| +3 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +4 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (39)
See all 396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960732 | Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500 | 1996 | 24 |
| K962447 | Equinox Digital Eeg System | 1996 | 8 |
| K962157 | Model 1310 Neurolink Neuromonitoring System | 1996 | 1 |
| K961609 | Model 1220, or E-Net (54-62 CM) | 1996 | 0 |
| K960873 | Model 1210, Medium E-Net | 1996 | 0 |
| K960885 | Model 1240, Small E Net | 1996 | 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?
- Of its descendants, K960732 (Physiometrix, Inc., 1996) has gone furthest, with 24 descendants of its own.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K930080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K930080: E*Net Neuromonitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K930080
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026