510(k) Report

510(k) · Cleared

Cleared

S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08

K002478510(k) TraditionalCleared Oct 5, 200055-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, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Oct 5, 2000 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 87 devices in its family, counting itself, has a Class I recall. 86 later devices descend from it.

Decided
Oct 5, 2000
Review
55 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

86 later devices descend from it, 1 citing it directly. 1 of the 87 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared2006: 3 descendants cleared2008: 3 descendants cleared2011: 3 descendants cleared2007: 2 descendants cleared2010: 5 descendants cleared2009: 5 descendants cleared2012: 5 descendants cleared2017: 3 descendants cleared2013: 6 descendants cleared2018: 3 descendants cleared2014: 3 descendants cleared, 1 with a Class I recall12020: 4 descendants cleared2019: 4 descendants cleared2016: 3 descendants cleared2015: 4 descendants cleared2022: 8 descendants cleared2024: 3 descendants cleared2021: 2 descendants cleared2023: 6 descendants cleared2025: 6 descendants cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK002478 S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08Datex-Ohmeda, Inc. · 2000
  2. Descendant · cites it directly · 85 of its ownK022485 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and…Datex-Ohmeda · 2002
  3. Descendant · 2 generations on · 84 of its ownK041790 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and…Datex-Ohmeda · 2004
  4. Descendant · 3 generations on · 48 of its ownK053193 PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  5. Descendant · 4 generations on · 47 of its ownK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
  6. Descendant · 3 generations on · 34 of its ownK061185 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and…GE Healthcare · 2006

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12006: 32007: 22008: 32009: 52010: 52011: 32012: 52013: 62014: 32015: 42016: 32017: 32018: 32019: 42020: 42021: 22022: 82023: 62024: 32025: 62026: 3
2002high 8 (2022) · low 0 (2003)2026

Class I recalls in this family

  • K133576 Monitor B406 generations on · 2014

Most influential descendants

Showing 5 of 86 · See all
  • K022485Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A SoftwareDatex-Ohmeda · 2002 · cites it directly85descendants
  • K041790Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A SoftwareDatex-Ohmeda · 2004 · 2 generations on84descendants
  • K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 3 generations on48descendants
  • K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 4 generations on47descendants
  • K061185Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A SoftwareGE Healthcare · 2006 · 3 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002478S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08Datex-Ohmeda, Inc.2000—
+1K022485Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A SoftwareDatex-Ohmeda2002—
+2K041790Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A SoftwareDatex-Ohmeda2004—
+3K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+4K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007—
+3K061185Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A…GE Healthcare2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200630
200720
200830
200950
201050
201130
201250
201360
201431
201540
201630
201730
201830
201940
202040
202120
202280
202360
202430
202560
202630
FIG. 1 — Lineage of K002478, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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?

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

What descends from it? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K022485Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A SoftwareDatex-Ohmeda200285

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 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K022485 (Datex-Ohmeda, 2002) has gone furthest, with 85 descendants 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, Inc.

59 FDA decisions under this applicant name. See the company

  • K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026
  • K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
  • K213867Carestation 750/750cDatex-Ohmeda, Inc. · 20234 Class I recalls
  • K210384Carescape R860Datex-Ohmeda, Inc. · 2021
  • K172702Tec 820, Tec 850Datex-Ohmeda, Inc. · 20184 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/K002478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002478: S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002478

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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