510(k) · Cleared
ClearedEquinox Digital Eeg 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 Dec 12, 1996 as substantially equivalent to K930080 (Physiometrix, Inc., 1993) and 1 other predicate after a 171-day review. Its family tree reaches back 1 generation to 1991. 8 later devices descend from it.
- Decided
- Dec 12, 1996
- Review
- 171 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905435 (1991). 2 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905435 UniquantNeuroconcepts, Inc. · 1991
- This deviceK962447 Equinox Digital Eeg SystemPhysiometrix, Inc. · 1996
- Descendant · cites it directly · 7 of its ownK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- Descendant · 2 generations on · 6 of its ownK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK192753 NeuralScan SystemMedeia, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- Descendant · 3 generations on · 0 of its ownK253767 UB ERP SystemUniversal Brain · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141316Cognision Eeg/EP SystemNeuronetrix Solutions · 2015 · cites it directly7descendants
- K171781eVox SystemEvoke Neuroscience, Inc. · 2017 · 2 generations on6descendants
- K192753NeuralScan SystemMedeia, Inc. · 2020 · 2 generations on3descendants
- K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023 · 3 generations on1descendant
- K253767UB ERP SystemUniversal Brain · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905435 | Uniquant | Neuroconcepts, Inc. | 1991 | — |
| 0 (this device) | K962447 | Equinox Digital Eeg System | Physiometrix, Inc. | 1996 | — |
| +1 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| +2 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| +2 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| +3 | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
| +3 | K253767 | UB ERP System | Universal Brain | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K930080 | E*Net Neuromonitoring SystemSummary page 1…2 Contact: Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance (508) 670-2422 (800) 474-9746 Subject Device: Equinox™ Digital EEG System Predicate Device: K930080, HydroDot NeuroMonitoring System K905435B UNIQUANT™ System This submission describes an EEG recording system that is comprised o… | 1993 |
| * | K905435 | UniquantSummary page 1…latory Affairs & Quality Assurance (508) 670-2422 (800) 474-9746 Subject Device: Equinox™ Digital EEG System Predicate Device: K930080, HydroDot NeuroMonitoring System K905435B UNIQUANT™ System This submission describes an EEG recording system that is comprised of a combination of components described i… | 1991 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141316 | Cognision Eeg/EP System | 2015 | 7 |
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.
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 Equinox™ System has the same intended use as the Neuro Concepts UNIQUANT™ System, that is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals.
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/K962447 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962447: Equinox Digital Eeg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962447
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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