510(k) · Cleared
ClearedNeurograph Evoked Potential Systems (Eps), Model Eps-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thuris Corp. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 4, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 4, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK010669 Neurograph Evoked Potential Systems (Eps), Model Eps-1Thuris Corp. · 2001
- Descendant · cites it directly · 4 of its ownK050192 BRC Software ProductBrc Operations Pty Limited · 2005
- Descendant · cites it directly · 3 of its ownK112077 Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012
- Descendant · 2 generations on · 2 of its ownK121119 Bna Analysis SystemEiminda, Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK202588 BNA PlatformElminda, Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK253015 Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K050192BRC Software ProductBrc Operations Pty Limited · 2005 · cites it directly4descendants
- K112077Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012 · cites it directly3descendants
- K121119Bna Analysis SystemEiminda, Ltd. · 2014 · 2 generations on2descendants
- K202588BNA PlatformElminda, Ltd. · 2020 · 3 generations on1descendant
- K253015Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010669 | Neurograph Evoked Potential Systems (Eps), Model Eps-1 | Thuris Corp. | 2001 | — |
| +1 | K050192 | BRC Software Product | Brc Operations Pty Limited | 2005 | — |
| +1 | K112077 | Hbidb - Human Brian Index Software | Corscience GmbH & Co. KG | 2012 | — |
| +2 | K121119 | Bna Analysis System | Eiminda, Ltd. | 2014 | — |
| +3 | K202588 | BNA Platform | Elminda, Ltd. | 2020 | — |
| +4 | K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K050192 (Brc Operations Pty Limited, 2005) has gone furthest, with 4 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/K010669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010669: Neurograph Evoked Potential Systems (Eps), Model Eps-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010669
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026