510(k) Report

510(k) · Cleared

Cleared

Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories

K050835510(k) SpecialCleared May 6, 200535-day reviewClass II21 CFR 882.1400

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

GE Healthcare · OLW Index-Generating Electroencephalograph Software

Cleared on May 6, 2005 as substantially equivalent to K023459 (Datex-Ohmeda, 2003) after a 35-day review. Its family tree reaches back 5 generations to 1977. 7 later devices descend from it.

Decided
May 6, 2005
Review
35 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K761301 (1977). 9 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1994: 1 other ancestor2008: 2 descendants cleared2007: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK761301 · V-Trace Ecg Backpad · Ndm Corp. · 1977K961821 · Aspect Medical Systems Zipprep Eeg Sensor · Aspect Medical Systems, Inc. · 1996K994330 · Aspect Medical Systems Eeg Sensor, Model 186-0076 · Aspect Medical Systems, Inc. · 2000K013389 · Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories · Datex-Ohmeda · 2002K023459 · Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories · Datex-Ohmeda · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K023459 · Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories · Datex-Ohmeda · 2003K013389 · Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories · Datex-Ohmeda · 2002K994330 · Aspect Medical Systems Eeg Sensor, Model 186-0076 · Aspect Medical Systems, Inc. · 2000K961821 · Aspect Medical Systems Zipprep Eeg Sensor · Aspect Medical Systems, Inc. · 1996K761301 · V-Trace Ecg Backpad · Ndm Corp. · 1977−50
  1. Root · 5 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
  2. 4 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. 3 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. 2 generations backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. 1 generation backK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. This deviceK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
  7. Descendant · cites it directly · 4 of its ownK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007
  8. Descendant · cites it directly · 2 of its ownK061907 Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and…GE Healthcare · 2008
  9. Descendant · 2 generations on · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
  10. Descendant · 2 generations on · 1 of its ownK082540 GE Entropy SensorGE Healthcare · 2008
  11. Descendant · 3 generations on · 0 of its ownK240668 Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22011: 12015: 12023: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all
  • K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007 · cites it directly4descendants
  • K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2008 · cites it directly2descendants
  • K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023 · 2 generations on1descendant
  • K082540GE Entropy SensorGE Healthcare · 2008 · 2 generations on1descendant
  • K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K761301V-Trace Ecg BackpadNdm Corp.1977—
−4K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.1996—
−3K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.2000—
−2K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda2002—
−1K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda2003—
0 (this device)K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare2005—
+1K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare2007—
+1K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare2008—
+2K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.2023—
+2K082540GE Entropy SensorGE Healthcare2008—
+3K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201110
201510
202310
202410
FIG. 1 — Lineage of K050835, 1977–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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. #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 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
*K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories
Summary page 1
…e, E-ENTROPY and accessories are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M- ENTROPY Module (K023459) Page 2 of 4 DEV…
Datex-Ohmeda2003—

Also cleared against K023459: 1 other device →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare20074
K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare20082

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 2.3 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K062580 (GE Healthcare, 2007) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K023459.

How does its category compare?

All OLW devices

OLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLW

1in 2024

2007: 32008: 22015: 12018: 12021: 12022: 12023: 12024: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLW

105in 2007

2007: 105 days median
2007high 105 (2007)2026

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

2017: 32018: 32019: 62020: 152021: 152022: 272023: 182024: 932025: 73
2007high 93 (2024) · low 0 (2007)2025

MAUDE reports naming product code OLW, 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
2007310500
20082—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—03
20181—03
20190—06
20200—015
20211—015
20221—027
20231—018
20241—093
20250—073
20262—0—

What is it indicated for?

The Datex-Ohmeda Entropy Module, E-ENTROPY and accessories are indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

Also cleared against K023459

1 other device cites the same predicate.

  • K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007

More from GE Healthcare

223 FDA decisions under this applicant name. See the company

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  • P110006/S011Invenia ABUS Premium, Invenia ABUS PrimeGE Healthcare · 2025
  • K232346Digital Expert Access with Remote ScanningGE Healthcare · 2023

Recent decisions in OLW

The OLW category page

  • K260907BIS™ Advance pEEG ModuleCovidien LP · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K230693BIS™ Advance Monitoring SystemCovidien, LLC · 2024
  • K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd. · 2023
  • K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation · 2022

https://510kreport.com/device/K050835 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy 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/K050835

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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