510(k) · Cleared
ClearedCeegraph, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Mar 3, 1994 after a 316-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 14 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Mar 3, 1994
- Review
- 316 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- This deviceK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
- Descendant · cites it directly · 12 of its ownK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
- Descendant · 2 generations on · 6 of its ownK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- Descendant · 3 generations on · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
- Descendant · 4 generations on · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · 2 generations on · 4 of its ownK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131882 Geodesiceeg System 400 Series (Ges 400)4 generations on · 2014
Most influential descendants
Showing 5 of 13 · See all- K973883Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998 · cites it directly12descendants
- K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000 · 2 generations on6descendants
- K050425Aura-PSGAstro-Med, Inc. · 2005 · 3 generations on5descendants
- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · 4 generations on4descendants
- K012079Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933233 | Ceegraph, Modification | Bio-Logic Systems Corp. | 1994 | — |
| +1 | K973883 | Bio-Logic Ceegraph 128-Channel Recording System | Bio-Logic Systems Corp. | 1998 | — |
| +2 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| +3 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| +4 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +2 | K012079 | Geodesic Eeg System, Model 200 | Electrical Geodesics, Incorporated | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973883 | Bio-Logic Ceegraph 128-Channel Recording System | 1998 | 12 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131882Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K973883 (Bio-Logic Systems Corp., 1998) has gone furthest, with 12 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/K933233 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933233: Ceegraph, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933233
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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