510(k) · Cleared
ClearedE-Eegx, N-Eegx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Jan 22, 2020 as substantially equivalent to K051883 (GE Healthcare, 2005) after a 252-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 22, 2020
- Review
- 252 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000892 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000892 Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg…Datex-Ohmeda, Inc. · 2000
- 1 generation backK051883 Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox…GE Healthcare · 2005
- This deviceK191322 E-Eegx, N-EegxGE Healthcare Finland Oy · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000892 | Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and… | Datex-Ohmeda, Inc. | 2000 | — |
| −1 | K051883 | Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and… | GE Healthcare | 2005 | — |
| 0 (this device) | K191322 | E-Eegx, N-Eegx | GE Healthcare Finland Oy | 2020 | — |
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 OLT? 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 |
|---|---|---|---|
| * | K051883 | Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and…Summary page 5…1 510(k) number K191322 Product Code OLT Subsequent Product Codes: GWJ, MHX, MLD, OMC, ORT Predicate Device(s) K051883 Datex-Ohmeda S/5 EEG Module, E-EEG and Datex- (807.92(a)(3): Ohmeda S/5 EEG Headbox, N-EEG and Accessories Devic… | 2005 |
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 20 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- None of the 2 ancestors has a recall.
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. 2020, 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 GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191322: E-Eegx, N-Eegx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191322
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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