510(k) Report

510(k) · Cleared

Recalled · Class I · 2021

Geodesiceeg System 400 Series (Ges 400)

K131882510(k) TraditionalCleared Feb 12, 2014232-day reviewClass II21 CFR 882.1400Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Electrical Geodesics, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software

Cleared on Feb 12, 2014 as substantially equivalent to K063797 (Electrical Geodesics, Incorporated, 2007) after a 232-day review. Its family tree reaches back 4 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
Feb 12, 2014
Review
232 days
Class
Class II
Product code
OLT
Recalls
1 (1 Class I)
Predicates
1

Its longest line of descent runs back 4 generations to K933233 (1994). 5 ancestors in all, the oldest K780045 (1978). No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1978: 1 other ancestorReference device: K112353 · Geodesic Eeg Mobile 100 (Gem 100) · Electrical Geodesics, Inc. · 2012K933233 · Ceegraph, Modification · Bio-Logic Systems Corp. · 1994K973883 · Bio-Logic Ceegraph 128-Channel Recording System · Bio-Logic Systems Corp. · 1998K012079 · Geodesic Eeg System, Model 200 · Electrical Geodesics, Incorporated · 2001K063797 · Geodesic Eeg System 300 · Electrical Geodesics, Incorporated · 20071980199020002010
Other ancestors, by generation 3 generations back: 1 other ancestor K063797 · Geodesic Eeg System 300 · Electrical Geodesics, Incorporated · 2007K012079 · Geodesic Eeg System, Model 200 · Electrical Geodesics, Incorporated · 2001K973883 · Bio-Logic Ceegraph 128-Channel Recording System · Bio-Logic Systems Corp. · 1998K933233 · Ceegraph, Modification · Bio-Logic Systems Corp. · 19940
  1. Root · 4 generations backK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
  2. 3 generations backK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
  3. 2 generations backK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001
  4. 1 generation backK063797 Geodesic Eeg System 300Electrical Geodesics, Incorporated · 2007
  5. This deviceK131882 Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K933233Ceegraph, ModificationBio-Logic Systems Corp.1994—
−3K973883Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp.1998—
−2K012079Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated2001—
−1K063797Geodesic Eeg System 300Electrical Geodesics, Incorporated2007—
0 (this device)K131882Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
FIG. 1 — Lineage of K131882, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253767 UB ERP Systemscore 14.9 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K063797Geodesic Eeg System 300
Summary page 1
…halograph, 882.1400, primary code OLT Non-normalizing quantitative electroencephalograph, secondary code GWQ electroencephalograph Legally Marketed Predicate Device(s) K063797 Geodesic BEG System Tm 300 (GES 300) by Electrical Ceodesics, Inc. Device Description The Geodesic EEC System Tm 400 S…
Electrical Geodesics, Incorporated2007—
†K112353Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc.2012—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 14, 2021Class IZ-1974-2021Device DesignThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
  • None of the 5 ancestors has a recall.

How does its category compare?

All OLT devices

OLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OLT

2in 2025

2007: 12008: 22009: 22013: 12014: 12015: 52019: 22020: 12022: 22024: 12025: 22026 (partial year): 3
2007high 5 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLT

266in 2015

2015: 266 days median2026 (partial year): 217 days median
2007high 266 (2015)2026

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

2016: 12017: 22018: 72019: 22020: 12021: 62022: 42023: 52024: 42025: 3
2007high 7 (2018) · low 0 (2007)2025

MAUDE reports naming product code OLT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20082—00
20092—00
20100—00
20110—00
20120—00
20131—00
20141—00
2015526600
20160—01
20170—02
20180—07
20192—02
20201—01
20210—06
20222—04
20230—05
20241—04
20252—03
202632170—

What is it indicated for?

The Geodesic EEG System 400 Series (GES 400) 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 as stated in the FDA summary.

More from Electrical Geodesics, Inc.

3 FDA decisions under this applicant name. See the company

  • K112353Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc. · 2012
  • K092844GeosourceElectrical Geodesics, Inc. · 2010

Recent decisions in OLT

The OLT category page

  • K261712Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026
  • K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
  • K253767UB ERP SystemUniversal Brain · 2026
  • K251881HippoMind (v1.0)Hippoclinic · 2025
  • K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator…Nihon Kohden Corporation · 2025

https://510kreport.com/device/K131882 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131882: Geodesiceeg System 400 Series (Ges 400).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131882

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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