510(k) Report

510(k) · Cleared

Cleared

CS/3 Critical Care Monitor with S-ICU99(a)

K000168510(k) TraditionalCleared Apr 13, 200084-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

Datex-Ohmeda · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Apr 13, 2000 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 13, 2000
Review
84 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK000168 CS/3 Critical Care Monitor with S-ICU99(a)Datex-Ohmeda · 2000
  2. Descendant · cites it directly · 1 of its ownK021376 Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A…Datex-Ohmeda · 2002
  3. Descendant · 2 generations on · 0 of its ownK071889 Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A…GE Healthcare · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K021376Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareDatex-Ohmeda · 2002 · cites it directly1descendant
  • K071889Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A SoftwareGE Healthcare · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000168CS/3 Critical Care Monitor with S-ICU99(a)Datex-Ohmeda2000—
+1K021376Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareDatex-Ohmeda2002—
+2K071889Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A SoftwareGE Healthcare2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200810
FIG. 1 — Lineage of K000168, 2000–2008Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MHX? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K021376Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareDatex-Ohmeda20021

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?

  • Of its descendants, K021376 (Datex-Ohmeda, 2002) has gone furthest, with 1 descendant of its own.

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.

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—

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

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https://510kreport.com/device/K000168 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000168: CS/3 Critical Care Monitor with S-ICU99(a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000168

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026