510(k) Report

510(k) · Cleared

Cleared

Entropy Module, E-ENTROPY-01

K150298510(k) TraditionalCleared Nov 12, 2015279-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 Filand OY · OLW Index-Generating Electroencephalograph Software

Cleared on Nov 12, 2015 as substantially equivalent to K061907 (GE Healthcare, 2008) after a 279-day review. Its family tree reaches back 7 generations to 1977.

Decided
Nov 12, 2015
Review
279 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K761301 (1977). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1994: 1 other ancestorK761301 · 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 · 2003K050835 · Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories · GE Healthcare · 2005K061907 · Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories · GE Healthcare · 20081980199020002010
Other ancestors, by generation 5 generations back: 3 other ancestors7 generations back: 1 other ancestor K061907 · Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories · GE Healthcare · 2008K050835 · Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories · GE Healthcare · 2005K023459 · 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 · 7 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
  2. 6 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. 5 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. 4 generations backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. 3 generations backK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. 2 generations backK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
  7. 1 generation backK061907 Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and…GE Healthcare · 2008
  8. This deviceK150298 Entropy Module, E-ENTROPY-01Ge Healthcare Filand OY · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K761301V-Trace Ecg BackpadNdm Corp.1977—
−6K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.1996—
−5K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.2000—
−4K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda2002—
−3K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda2003—
−2K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare2005—
−1K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare2008—
0 (this device)K150298Entropy Module, E-ENTROPY-01Ge Healthcare Filand OY2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200020
200110
FIG. 1 — Lineage of K150298, 1977–2015Source: 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
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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
*K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories
Summary page 5
…Code: 510(k) Summary ENTROPY MODULE, E-ENTROPY-01 Page 1 Predicate Device(s) K061907 Datex-Ohmeda S/5™ Entropy Module, (807.92(a)(3): E-ENTROPY-00 Device Description GE Healthcare Entropy Module…
GE Healthcare2008—

Also cleared against K061907: 1 other device →

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 38 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
  • None of the 11 ancestors has a recall.
  • 1 other device also cites its predicate K061907.

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. 2015, this device’s year, is highlighted.

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 GE Healthcare Entropy module, E-ENTROPY, and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which are processed EEG and FEMG variables. The Entropy…

Read the full statement (153 words)

The GE Healthcare Entropy module, E-ENTROPY, and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals.

The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters.

In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia.

The Entropy module is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

Also cleared against K061907

1 other device cites the same predicate.

  • K103129Entropy Easyfit SensorGE Healthcare · 2011

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/K150298 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150298: Entropy Module, E-ENTROPY-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150298

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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