510(k) · Cleared
ClearedGeodesic Eeg Mobile 100 (Gem 100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrical Geodesics, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Feb 17, 2012 as substantially equivalent to K033399 (Electrical Geodesics, Incorporated, 2004) after a 185-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Feb 17, 2012
- Review
- 185 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- 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.
- Root · 4 generations backK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
- 3 generations backK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
- 2 generations backK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001
- 1 generation backK033399 Geodesic Eeg System Series 100Electrical Geodesics, Incorporated · 2004
- This deviceK112353 Geodesic Eeg Mobile 100 (Gem 100)Electrical Geodesics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933233 | Ceegraph, Modification | Bio-Logic Systems Corp. | 1994 | — |
| −3 | K973883 | Bio-Logic Ceegraph 128-Channel Recording System | Bio-Logic Systems Corp. | 1998 | — |
| −2 | K012079 | Geodesic Eeg System, Model 200 | Electrical Geodesics, Incorporated | 2001 | — |
| −1 | K033399 | Geodesic Eeg System Series 100 | Electrical Geodesics, Incorporated | 2004 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K033399 | Geodesic Eeg System Series 100Summary page 1…e Name Trade Name: Geodesic BEG Mobile 100 (GEM 100) Common Name: BEG Classification Name: Electroencephalograph, 882.1 460,GWQ Le2aIlv Marketed Predicate Device(s) K033399, GWQ, Geodesic BEG System 100, Model 120, Electrical Geodesics, Inc. Device Description The Geodesic EEG Mobile 100 (GEM 100) i… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Mobile 100 (GEM 100) 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.
https://510kreport.com/device/K112353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112353: Geodesic Eeg Mobile 100 (Gem 100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112353
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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