510(k) · Cleared
ClearedGeodesic Eeg System 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrical Geodesics, Incorporated · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Jan 25, 2007 as substantially equivalent to K012079 (Electrical Geodesics, Incorporated, 2001) after a 34-day review. Its family tree reaches back 3 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 25, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- OLT
- 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. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- 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 deviceK063797 Geodesic Eeg System 300Electrical Geodesics, Incorporated · 2007
- Descendant · cites it directly · 0 of its ownK131882 Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · Recalled (Class I)
Class I recalls in this family
- K131882 Geodesiceeg System 400 Series (Ges 400)cites it directly · 2014
Most influential descendants
Showing 1 of 1 · See all- K131882Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · 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) | K063797 | Geodesic Eeg System 300 | Electrical Geodesics, Incorporated | 2007 | — |
| +1 | K131882 | Geodesiceeg System 400 Series (Ges 400) | Electrical Geodesics, Inc. | 2014 | Class I |
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 |
|---|---|---|
| 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 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…oencephalograph, 84 GWQ Class 11, 882.1400 Legally marketed device for substantial equivalence comparison: Geodesic EEG System™ submitted by Electrical Geodesics, Inc. K012079 Description of the device: The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated… | 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 |
|---|---|---|---|
| K131882 | Geodesiceeg System 400 Series (Ges 400) Class I | 2014 | 0 |
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 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131882 (Electrical Geodesics, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012079.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The Geodesic EEG System™ 300 (GES 300) 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/K063797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063797: Geodesic Eeg System 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063797
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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