510(k) · Cleared
ClearedGeodesic Eeg System, Model 200
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 Sep 19, 2001 as substantially equivalent to K973883 (Bio-Logic Systems Corp., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1994. 1 of the 8 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Sep 19, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933233 (1994). 3 ancestors in all, the oldest K780045 (1978). 4 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
- 1 generation backK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
- This deviceK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001
- Descendant · cites it directly · 1 of its ownK063797 Geodesic Eeg System 300Electrical Geodesics, Incorporated · 2007
- Descendant · cites it directly · 1 of its ownK033399 Geodesic Eeg System Series 100Electrical Geodesics, Incorporated · 2004
- Descendant · 2 generations on · 0 of its ownK131882 Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK112353 Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc. · 2012
Class I recalls in this family
- K131882 Geodesiceeg System 400 Series (Ges 400)2 generations on · 2014
Most influential descendants
Showing 4 of 4 · See all- K063797Geodesic Eeg System 300Electrical Geodesics, Incorporated · 2007 · cites it directly1descendant
- K033399Geodesic Eeg System Series 100Electrical Geodesics, Incorporated · 2004 · cites it directly1descendant
- K131882Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · 2 generations on0descendants
- K112353Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933233 | Ceegraph, Modification | Bio-Logic Systems Corp. | 1994 | — |
| −1 | K973883 | Bio-Logic Ceegraph 128-Channel Recording System | Bio-Logic Systems Corp. | 1998 | — |
| 0 (this device) | K012079 | Geodesic Eeg System, Model 200 | Electrical Geodesics, Incorporated | 2001 | — |
| +1 | K063797 | Geodesic Eeg System 300 | Electrical Geodesics, Incorporated | 2007 | — |
| +1 | K033399 | Geodesic Eeg System Series 100 | Electrical Geodesics, Incorporated | 2004 | — |
| +2 | K131882 | Geodesiceeg System 400 Series (Ges 400) | Electrical Geodesics, Inc. | 2014 | Class I |
| +2 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 1 |
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? (2)
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 |
|---|---|---|---|
| * | K973883 | Bio-Logic Ceegraph 128-Channel Recording SystemSummary page 1…For the Geodesic EEG System it is the Bio-Logic Ceegraph 128-Channel Recording System submitted by Bio-Logic Systems Corporation and cleared for marketing under 510(k) *K973883. For the Geodesic Sensor Net, the predicate device is the Electro-Cap VII System submitted by Electro-Cap Inc. and cleared for ma… | 1998 |
| * | K780045 | Electrode CapSummary page 1…er 510(k) *K973883. For the Geodesic Sensor Net, the predicate device is the Electro-Cap VII System submitted by Electro-Cap Inc. and cleared for marketing under 510(k) “K780045. Description of the device: The Geodesic EEG System is a digital electroencephalography system (EEG) with a dense sensor array o… | 1978 |
What descends from it? (4)
2 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 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063797 (Electrical Geodesics, Incorporated, 2007) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K973883.
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 System is intended to measure and record the electrical activity of the patient’s brain. It can be used on adults, children, and infants.
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/K012079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012079: Geodesic Eeg System, Model 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012079
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026