510(k) · Cleared
ClearedCumulus Functional Neurophysiology Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cumulus Neuroscience Limited · GWQ Full-Montage Standard Electroencephalograph
Cleared on Apr 27, 2023 as substantially equivalent to K192753 (Medeia, Inc., 2020) after a 296-day review. Its family tree reaches back 11 generations to 1987. 1 later device descends from it.
- Decided
- Apr 27, 2023
- Review
- 296 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K873535 (1987). 46 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 7 generations between
- 3 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 2 generations backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- 1 generation backK192753 NeuralScan SystemMedeia, Inc. · 2020
- This deviceK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
- Descendant · cites it directly · 0 of its ownK253767 UB ERP SystemUniversal Brain · 2026
Show all 11 generations
- Root · 11 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 10 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 9 generations backK072014 VitascoreVitascore B.V. · 2007
- 8 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 7 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 6 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 5 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 4 generations backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- 3 generations backK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
- 2 generations backK171781 eVox SystemEvoke Neuroscience, Inc. · 2017
- 1 generation backK192753 NeuralScan SystemMedeia, Inc. · 2020
- This deviceK221963 Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K253767UB ERP SystemUniversal Brain · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −10 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −9 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −8 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −7 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −6 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −5 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −4 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| −3 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
| −2 | K171781 | eVox System | Evoke Neuroscience, Inc. | 2017 | — |
| −1 | K192753 | NeuralScan System | Medeia, Inc. | 2020 | — |
| 0 (this device) | K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023 | — |
| +1 | K253767 | UB ERP System | Universal Brain | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K192753 | NeuralScan SystemSummary page 4…alograph Regulatory Name Full-montage standard EEG Classification 882.1400 Product Code GWQ III. PREDICATE DEVICE Primary Predicate K192753, NeuralScan System, Medeia, Inc. IV. INDICATIONS FOR USE STATEMENT The Cumulus Functional Neurophysiology Platform is intended f… | 2020 |
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 |
|---|---|---|---|
| K253767 | UB ERP System | 2026 | 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?
- The line of descent spans 36 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 46 ancestors have a recall of any class.
- Of its descendants, K253767 (Universal Brain, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K192753.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped.
The system can be used in the patient’s home or a health care facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221963 · printed Nov 3, 2026
Cite this page
510(k) Report. “K221963: Cumulus Functional Neurophysiology Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K221963
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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