510(k) · Cleared
ClearedBio-Logic Ceegraph 128-Channel Recording System
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 5, 1998 as substantially equivalent to K933233 (Bio-Logic Systems Corp., 1994) after a 142-day review. Its family tree reaches back 1 generation to 1994. 1 of the 14 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Mar 5, 1998
- Review
- 142 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933233 (1994). 12 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
- This deviceK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
- Descendant · cites it directly · 6 of its ownK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- Descendant · 2 generations on · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
- Descendant · 3 generations on · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · cites it directly · 4 of its ownK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001
- Descendant · 4 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131882 Geodesiceeg System 400 Series (Ges 400)3 generations on · 2014
Most influential descendants
Showing 5 of 12 · See all- K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000 · cites it directly6descendants
- K050425Aura-PSGAstro-Med, Inc. · 2005 · 2 generations on5descendants
- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · 3 generations on4descendants
- K012079Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001 · cites it directly4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933233 | Ceegraph, Modification | Bio-Logic Systems Corp. | 1994 | — |
| 0 (this device) | K973883 | Bio-Logic Ceegraph 128-Channel Recording System | Bio-Logic Systems Corp. | 1998 | — |
| +1 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| +2 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| +3 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +1 | K012079 | Geodesic Eeg System, Model 200 | Electrical Geodesics, Incorporated | 2001 | — |
| +4 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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 |
|---|---|---|---|
| * | K933233 | Ceegraph, ModificationSummary page 1…em. COMMON NAME: Digital EEG Recorder. CLASSIFICATION NAME: Electroencephalograph (per CFR 882.1400). PREDICATE DEVICE: Bio-logic Ceegraph Digital EEG System , 510(k) #K933233. DESCRIPTION OF THE DEVICE: The 128-Channel data collection system consists of a metal enclosure approximately 13.5” x 7.375” x… | 1994 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K994142 (Grass Instrument Co., 2000) has gone furthest, with 6 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 | — |
What is it indicated for?
The Bio-logic Ceegraph family is indicated for use in the recording and analysis of routine EEG tests. Typical EEG tests are 20-30 minutes in duration. but the Ceegraph system can also be used for longer tests. including continuous long-term EEG monitoring with patient video. EEG testing is indicated for use whenever it is necessary to measure and record the electrical activity of a patient’s brain by attaching multiple electrodes at various locations on…
Read the full statement (114 words)
The Bio-logic Ceegraph family is indicated for use in the recording and analysis of routine EEG tests. Typical EEG tests are 20-30 minutes in duration. but the Ceegraph system can also be used for longer tests. including continuous long-term EEG monitoring with patient video. EEG testing is indicated for use whenever it is necessary to measure and record the electrical activity of a patient’s brain by attaching multiple electrodes at various locations on the scalp.
The 128 Channel Data Recording system has a similar intended use to that of the 32 channel Ceegraph recording system.
It can be used for patients of all ages. from newborn infants through aduits. to and including geriatric patients.
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/K973883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973883: Bio-Logic Ceegraph 128-Channel Recording System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973883
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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