510(k) Report

510(k) · Cleared

Cleared

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

K013389510(k) TraditionalCleared Jan 10, 200290-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 10, 2002 as substantially equivalent to K011534 (Aspect Medical Systems, Inc., 2001) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1977. 10 later devices descend from it.

Decided
Jan 10, 2002
Review
90 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K761301 (1977). 7 ancestors in all. 10 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: 2 descendants cleared2003: 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. · 200019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants K994330 · 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 · 3 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
  2. 2 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. 1 generation backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. This deviceK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. Descendant · cites it directly · 8 of its ownK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. Descendant · 2 generations on · 7 of its ownK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
  7. Descendant · 2 generations on · 4 of its ownK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007
  8. Descendant · 3 generations on · 2 of its ownK061907 Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and…GE Healthcare · 2008
  9. Descendant · 3 generations on · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003: 12005: 22007: 12008: 22011: 12015: 12023: 12024: 1
2003high 2 (2005) · low 0 (2004)2026

Most influential descendants

Showing 5 of 10 · See all
  • K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003 · cites it directly8descendants
  • K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005 · 2 generations on7descendants
  • K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007 · 2 generations on4descendants
  • K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2008 · 3 generations on2descendants
  • K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200520
200710
200820
201110
201510
202310
202410
FIG. 1 — Lineage of K013389, 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? (4)

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
*K011534Eeg Mis Monitor Model # a-2000; Bis Engine
Summary page 1
…pared to a legally marketed device (predicate). A comparison is made between the Datex-Ohmeda BIS Module and the predicate device, Aspect Medical Systems Inc. BIS Engine K011534. Accessories for both the Datex- Chmeda BIS module M-BIS, and predicate device are the same as those cleared for Aspect Medical S…
Aspect Medical Systems, Inc.2001—
*K994330Aspect Medical Systems Eeg Sensor, Model 186-0076
Summary page 1
…Inc. BIS Engine K011534. Accessories for both the Datex- Chmeda BIS module M-BIS, and predicate device are the same as those cleared for Aspect Medical Systems Inc under K994330, K002734 and K001980. Page 2 of 5 DEVICE DESCRI N as required by 807.92(a¥4 The Datex-Ohmeda BIS module, M-BIS…
Aspect Medical Systems, Inc.2000—
*K002734Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106
Summary page 1
…Engine K011534. Accessories for both the Datex- Chmeda BIS module M-BIS, and predicate device are the same as those cleared for Aspect Medical Systems Inc under K994330, K002734 and K001980. Page 2 of 5 DEVICE DESCRI N as required by 807.92(a¥4 The Datex-Ohmeda BIS module, M-BIS is a sing…
Aspect Medical Systems, Inc.2000—
*K001980Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110
Summary page 1
…34. Accessories for both the Datex- Chmeda BIS module M-BIS, and predicate device are the same as those cleared for Aspect Medical Systems Inc under K994330, K002734 and K001980. Page 2 of 5 DEVICE DESCRI N as required by 807.92(a¥4 The Datex-Ohmeda BIS module, M-BIS is a single-width plu…
Aspect Medical Systems, Inc.2000—

Also cleared against K011534: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda20038
K052145Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare20050

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 25 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K023459 (Datex-Ohmeda, 2003) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K011534.

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 BIS module, M-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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K011534

2 other devices cite the same predicate.

  • K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
  • K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003

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/K013389 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013389: Datex-Ohmeda S/5 Bis Module, M-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/K013389

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026