510(k) Report

510(k) · Cleared

Cleared

AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)

K000815510(k) TraditionalCleared Jun 8, 200087-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 Jun 8, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 57 devices in its family, counting itself, has a Class I recall. 56 later devices descend from it.

Decided
Jun 8, 2000
Review
87 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

56 later devices descend from it, 1 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2009: 3 descendants cleared2008: 1 descendant cleared2012: 2 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2014: 2 descendants cleared, 1 with a Class I recall12013: 6 descendants cleared2017: 1 descendant cleared2020: 5 descendants cleared2016: 2 descendants cleared2015: 4 descendants cleared2019: 1 descendant cleared2022: 6 descendants cleared2023: 4 descendants cleared2025: 5 descendants cleared2024: 2 descendants cleared2021: 1 descendant cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
  2. Descendant · cites it directly · 55 of its ownK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
  3. Descendant · 2 generations on · 54 of its ownK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
  4. Descendant · 3 generations on · 48 of its ownK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
  5. Descendant · 4 generations on · 38 of its ownK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
  6. Descendant · 4 generations on · 33 of its ownK092680 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A…GE Healthcare Finland Oy · 2009

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12006: 12007: 22008: 12009: 32010: 22011: 12012: 22013: 62014: 22015: 42016: 22017: 12019: 12020: 52021: 12022: 62023: 42024: 22025: 52026: 3
2002high 6 (2013) · low 0 (2004)2026

Class I recalls in this family

  • K133576 Monitor B407 generations on · 2014

Most influential descendants

Showing 5 of 56 · See all
  • K021279Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002 · cites it directly55descendants
  • K030812Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003 · 2 generations on54descendants
  • K051400Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or…GE Healthcare · 2006 · 3 generations on48descendants
  • K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · 4 generations on38descendants
  • K092680Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or…GE Healthcare Finland Oy · 2009 · 4 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000815AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda2000—
+1K021279Datex-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—
+3K051400Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using…GE Healthcare2006—
+4K092027Carescape Monitor B850Ge Medical Systems Information Technologies20099
+4K092680Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using…GE Healthcare Finland Oy2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200610
200720
200810
200930
201020
201110
201220
201360
201421
201540
201620
201710
201910
202050
202110
202260
202340
202420
202550
202630
FIG. 1 — Lineage of K000815, 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), 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
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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? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K021279Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda200255

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

What does this lineage say?

  • Of its descendants, K021279 (Datex-Ohmeda, 2002) has gone furthest, with 55 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

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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The MHX category page

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  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
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https://510kreport.com/device/K000815 · printed Nov 3, 2026

Cite this page

510(k) Report. “K000815: AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K000815

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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