510(k) · Cleared
ClearedDatex-Ohmeda S/5 Bis Module, E-Bis and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · OLW Index-Generating Electroencephalograph Software
Cleared on Aug 23, 2005 as substantially equivalent to K013389 (Datex-Ohmeda, 2002) after a 15-day review. Its family tree reaches back 4 generations to 1977.
- Decided
- Aug 23, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K761301 (1977). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
- 3 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
- 2 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
- 1 generation backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
- This deviceK052145 Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K761301 | V-Trace Ecg Backpad | Ndm Corp. | 1977 | — |
| −3 | K961821 | Aspect Medical Systems Zipprep Eeg Sensor | Aspect Medical Systems, Inc. | 1996 | — |
| −2 | K994330 | Aspect Medical Systems Eeg Sensor, Model 186-0076 | Aspect Medical Systems, Inc. | 2000 | — |
| −1 | K013389 | Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories | Datex-Ohmeda | 2002 | — |
| 0 (this device) | K052145 | Datex-Ohmeda S/5 Bis Module, E-Bis and Accessories | GE Healthcare | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 OLW? 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 OLW device
- #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 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 |
|---|---|---|---|
| * | K013389 | Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesSummary page 4…/5TM BIS Module, E-BIS is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-BIS Module (K013389). The E-BIS module has the following similarities compared to the predicate M-BIS (K013389):… | 2002 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K013389.
How does its category compare?
All OLW devicesOLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLW
105in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLW
No recall names OLW since 2007.
Adverse event reports per year · OLW
73in 2025
MAUDE reports naming product code OLW, 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 | 3 | 105 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 93 |
| 2025 | 0 | — | 0 | 73 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Datex-Ohmeda S/5 T BIS Module, E-BIS and accessories are indicated for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) signals of all hospitalized patients.
The Bispectral index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052145: Datex-Ohmeda S/5 Bis Module, E-Bis and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052145
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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