510(k) Report

510(k) · Cleared

Cleared

Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories

K023459510(k) TraditionalCleared Jan 13, 200390-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

Datex-Ohmeda · OLW Index-Generating Electroencephalograph Software

Cleared on Jan 13, 2003 as substantially equivalent to K013389 (Datex-Ohmeda, 2002) after a 90-day review. Its family tree reaches back 4 generations to 1977. 8 later devices descend from it.

Decided
Jan 13, 2003
Review
90 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. 8 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 ancestor2005: 1 descendant cleared2007: 1 descendant cleared2008: 2 descendants cleared2023: 1 descendant cleared2015: 1 descendant cleared2011: 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 · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K013389 · 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. · 19770
  1. Root · 4 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
  2. 3 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. 2 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. 1 generation backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. This deviceK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. Descendant · cites it directly · 7 of its ownK050835 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 · 2 generations on · 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

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12008: 22011: 12015: 12023: 12024: 1
2005high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all
  • K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005 · cites it directly7descendants
  • 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 · 2 generations on2descendants
  • K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023 · 2 generations on1descendant
  • K082540GE Entropy SensorGE Healthcare · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K761301V-Trace Ecg BackpadNdm Corp.1977—
−3K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.1996—
−2K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.2000—
−1K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda2002—
0 (this device)K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda2003—
+1K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare2005—
+1K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare2007—
+2K061907Modification 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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200820
201110
201510
202310
202410
FIG. 1 — Lineage of K023459, 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
*K013389Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories
Summary page 1
…a Entropy Module, M-ENTROPY and accessories is substantially equivalent in safety and effectiveness to the legally marketed predicate Datex-Ohmeda S/5™ BIS module M-BIS (K013389). Page 2 of 3 DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda Entropy module, M-ENTROPY is a si…
Datex-Ohmeda2002—

Also cleared against K013389: 1 other device →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare20057
K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare20074

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 26 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K050835 (GE Healthcare, 2005) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K013389.

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 is 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, State Entropy (SE) and Response Entropy (RE), 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K013389

1 other device cites the same predicate.

  • K052145Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare · 2005

More from Datex-Ohmeda

40 FDA decisions under this applicant name. See the company

  • K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 20132 recalls
  • K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 20121 Class I recall
  • K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 20113 Class I recalls
  • K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
  • K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda · 2005

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/K023459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023459: Datex-Ohmeda S/5 Entropy Module, M-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/K023459

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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