510(k) Report

510(k) · Cleared

Cleared

Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or F-CU5 (P) Monitor Frame Options an

K092680510(k) SpecialCleared Sep 23, 200922-day reviewClass II21 CFR 870.1025

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

GE Healthcare Finland Oy · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Sep 23, 2009 as substantially equivalent to K051400 (GE Healthcare, 2006) after a 22-day review. Its family tree reaches back 4 generations to 2000. 1 of the 38 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.

Decided
Sep 23, 2009
Review
22 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K000815 (2000). 33 later devices descend from it, 1 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2010: 1 descendant cleared2017: 1 descendant cleared2013: 4 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared, 1 with a Class I recall12020: 4 descendants cleared2019: 1 descendant cleared2015: 2 descendants cleared2022: 5 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2025: 5 descendants cleared2024: 2 descendants cleared2026: 2 descendants clearedK000815 · AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) · Datex-Ohmeda · 2000K021279 · Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software · Datex-Ohmeda · 2002K030812 · Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software · Datex-Ohmeda · 2003K051400 · Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options · GE Healthcare · 2006200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 6 descendants, 1 with a Class I recall14 generations forward: 6 descendants5 generations forward: 6 descendants6 generations forward: 4 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants K051400 · Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options · GE Healthcare · 2006K030812 · Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software · Datex-Ohmeda · 2003K021279 · Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software · Datex-Ohmeda · 2002K000815 · AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) · Datex-Ohmeda · 20000+5
  1. Root · 4 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
  2. 3 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
  3. 2 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
  4. 1 generation backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
  5. This deviceK092680 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A…GE Healthcare Finland Oy · 2009
  6. Descendant · cites it directly · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
  7. Descendant · 2 generations on · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
  8. Descendant · 2 generations on · 13 of its ownK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
  9. Descendant · 3 generations on · 11 of its ownK190008 Carescape OneGE Healthcare · 2019
  10. Descendant · 4 generations on · 10 of its ownK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 42014: 12015: 22017: 12019: 12020: 42021: 12022: 52023: 32024: 22025: 52026: 2
2010high 5 (2022) · low 0 (2011)2026

Class I recalls in this family

  • K133576 Monitor B403 generations on · 2014

Most influential descendants

Showing 5 of 33 · See all
  • K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · cites it directly32descendants
  • K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · 2 generations on14descendants
  • K131223Carescape Monitor B650GE Healthcare Finland Oy · 2013 · 2 generations on13descendants
  • K190008Carescape OneGE Healthcare · 2019 · 3 generations on11descendants
  • K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare · 2020 · 4 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000815AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda2000—
−3K021279Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda2002—
−2K030812Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda2003—
−1K051400Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using…GE Healthcare2006—
0 (this device)K092680Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using…GE Healthcare Finland Oy2009—
+1K102239Carescape Monitor B650GE Healthcare Finland Oy20108
+2K132533Carescape Monitor B450GE Healthcare Finland Oy20133
+2K131223Carescape Monitor B650GE Healthcare Finland Oy20134
+3K190008Carescape OneGE Healthcare2019—
+4K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE…GE Healthcare20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201340
201411
201520
201710
201910
202040
202110
202250
202330
202420
202550
202620
FIG. 1 — Lineage of K092680, 2000–2026Source: 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.

1 device in this family has a Class I recall. 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 MHX device

  1. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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
*K051400Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or…
Summary page 1
…SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS AND E- EXT EXTENSION MODULE AND E-REC RECORDER MODULE 1K051400) Device Description: The S/5 Anesthesia Monitor is a patient monitor, which displays the…
GE Healthcare2006—

Also cleared against K051400: 2 other devices →

What descends from it? (33)

See all 33

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102239Carescape Monitor B650GE Healthcare Finland Oy201032

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K102239 (GE Healthcare Finland Oy, 2010) has gone furthest, with 32 descendants of its own.
  • 2 other devices also cite its predicate K051400.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/S Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory; gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status…

Read the full statement (222 words)

The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation.

The S/S Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory; gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients.

When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

Also cleared against K051400

2 other devices cite the same predicate.

  • K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 20099 recalls
  • K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007

More from GE Healthcare Finland Oy

32 FDA decisions under this applicant name. See the company

  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)GE Healthcare Finland Oy · 20233 recalls
  • K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy · 20221 recall
  • K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy · 20222 recalls

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K092680 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092680: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or F-CU5 (P) Monitor Frame Options an.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092680

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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