510(k) · Cleared
ClearedDatex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and Accessories.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Aug 5, 2005 as substantially equivalent to K000892 (Datex-Ohmeda, Inc., 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Aug 5, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000892 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000892 Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg…Datex-Ohmeda, Inc. · 2000
- This deviceK051883 Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox…GE Healthcare · 2005
- Descendant · cites it directly · 0 of its ownK191322 E-Eegx, N-EegxGE Healthcare Finland Oy · 2020
Most influential descendants
Showing 1 of 1 · See all- K191322E-Eegx, N-EegxGE Healthcare Finland Oy · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000892 | Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and… | Datex-Ohmeda, Inc. | 2000 | — |
| 0 (this device) | K051883 | Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and… | GE Healthcare | 2005 | — |
| +1 | K191322 | E-Eegx, N-Eegx | GE Healthcare Finland Oy | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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 |
|---|---|---|---|
| * | K000892 | Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and AccessoriesSummary page 2…ex-Ohmeda S/5™ EEG Headbox, N-EEG and accessories is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M- EEG Module (K000892). DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda S/5™ EEG module, E-EEG is a single-width plug-in parameter mo… | 2000 |
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 |
|---|---|---|---|
| K191322 | E-Eegx, N-Eegx | 2020 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K191322 (GE Healthcare Finland Oy, 2020) has gone furthest, with 0 descendants of its own.
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.
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 Datex-Ohmeda S/5™ EEG module, E-EEG and the Datex-Ohmeda S/5™ EEG headbox, N-EEG and accessories are indicated for monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG) and auditory evoked potentials (AEP) of all hospital patients.
The device is indicated for use by qualified medical personnel only.
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/K051883 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051883: Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and Accessories..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051883
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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