510(k) Report

510(k) · Cleared

Recalled · 2003

Agilent Information Center Software for M3150,M3151,M3153 and M3154

K011093510(k) SpecialCleared May 1, 200121-day reviewClass II21 CFR 870.1025Recalls 4

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

Agilent Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 1, 2001 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 442 later devices descend from it. It has been recalled 4 times.

Decided
May 1, 2001
Review
21 days
Class
Class II
Product code
MHX
Recalls
4
Predicates
0

442 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 4 descendants cleared2003: 5 descendants cleared2006: 15 descendants cleared2008: 16 descendants cleared2010: 21 descendants cleared2007: 8 descendants cleared2004: 9 descendants cleared2005: 10 descendants cleared2009: 16 descendants cleared2013: 19 descendants cleared2014: 18 descendants cleared2011: 19 descendants cleared2012: 20 descendants cleared2015: 17 descendants cleared2018: 26 descendants cleared2017: 22 descendants cleared2016: 16 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2020: 16 descendants cleared2023: 26 descendants cleared2019: 18 descendants cleared2025: 28 descendants cleared2024: 25 descendants cleared2026: 21 descendants cleared200020052010201520202025
  1. This deviceK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001
  2. Descendant · cites it directly · 426 of its ownK021422 Philips Information Center Software Revision D.02Philips Medical Systems · 2002
  3. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  4. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  5. Descendant · 3 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  6. Descendant · 3 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003

Showing 5 of 442 descendants. See all descendants

Descendants cleared per year

2002: 42003: 52004: 92005: 102006: 152007: 82008: 162009: 162010: 212011: 192012: 202013: 192014: 182015: 172016: 162017: 222018: 262019: 182020: 162021: 192022: 282023: 262024: 252025: 282026: 21
2002high 28 (2022) · low 4 (2002)2026

Most influential descendants

Showing 5 of 442 · See all
  • K021422Philips Information Center Software Revision D.02Philips Medical Systems · 2002 · cites it directly426descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants
  • K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants
  • K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 3 generations on404descendants
  • K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 3 generations on376descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011093Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc.2001—
+1K021422Philips Information Center Software Revision D.02Philips Medical Systems2002—
+2K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
+3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
+3K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200350
200490
2005100
2006150
200780
2008160
2009160
2010210
2011190
2012200
2013190
2014180
2015170
2016160
2017220
2018260
2019180
2020160
2021190
2022280
2023260
2024250
2025280
2026210
FIG. 1 — Lineage of K011093, 2001–2026Source: 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.

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? (442)

See all 442

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

NumberDeviceApplicantDecidedDescendants
K021422Philips Information Center Software Revision D.02Philips Medical Systems2002426
K031403M3290A Intellivue Information Center Software Release E.1Philips Medical Systems, Inc.2003263
K062194Hypervisor VI Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.200725
K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410
K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems20069
K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems20088
K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems20107

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 2, 2003Not classifiedZ-0596-03OtherCentral Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
Jan 2, 2003Not classifiedZ-0595-03OtherCentral Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
Jan 2, 2003Not classifiedZ-0594-03OtherCentral Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
Jan 2, 2003Not classifiedZ-0597-03OtherCentral Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K021422 (Philips Medical Systems, 2002) has gone furthest, with 426 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 Agilent Technologies, Inc.

105 FDA decisions under this applicant name. See the company

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  • P230016/S003MAGE-A4 IHC 1F9 pharmDxAgilent Technologies, Inc. · 2026
  • P150025/S020PD-L1 IHC 28-8 pharmDxAgilent Technologies, Inc. · 2026

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The MHX category page

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https://510kreport.com/device/K011093 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011093: Agilent Information Center Software for M3150,M3151,M3153 and M3154.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011093

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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