510(k) · Cleared
ClearedGeodesic Eeg System Series 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrical Geodesics, Incorporated · GWQ Full-Montage Standard Electroencephalograph
Cleared on Aug 4, 2004 as substantially equivalent to K012079 (Electrical Geodesics, Incorporated, 2001) after a 285-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Aug 4, 2004
- Review
- 285 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933233 (1994). 4 ancestors in all, the oldest K780045 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
- 2 generations backK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
- 1 generation backK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001
- This deviceK033399 Geodesic Eeg System Series 100Electrical Geodesics, Incorporated · 2004
- Descendant · cites it directly · 0 of its ownK112353 Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112353Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933233 | Ceegraph, Modification | Bio-Logic Systems Corp. | 1994 | — |
| −2 | K973883 | Bio-Logic Ceegraph 128-Channel Recording System | Bio-Logic Systems Corp. | 1998 | — |
| −1 | K012079 | Geodesic Eeg System, Model 200 | Electrical Geodesics, Incorporated | 2001 | — |
| 0 (this device) | K033399 | Geodesic Eeg System Series 100 | Electrical Geodesics, Incorporated | 2004 | — |
| +1 | K112353 | Geodesic Eeg Mobile 100 (Gem 100) | Electrical Geodesics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K012079 | Geodesic Eeg System, Model 200Summary page 1…icate device for this submission is the Geodesic EEG SystemnTm Model 200 submitted by Electrical Geodesics, Inc. and cleared for marketing under 5 10(k) #KO012079. Description of the device: The Geodesic BEG System TM Series 100 products, also known as the GES Series 100, are… | 2001 |
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 |
|---|---|---|---|
| K112353 | Geodesic Eeg Mobile 100 (Gem 100) | 2012 | 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 10 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112353 (Electrical Geodesics, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012079.
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 Geodesic EEG SystemTM Series 100 products are intended to measure and record the electrical activity of the patient's brain. They can be used on adults, children, and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033399: Geodesic Eeg System Series 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033399
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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