510(k) Report

510(k) · Cleared

Cleared

Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module

K001722510(k) SpecialCleared Jun 30, 200024-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

Agilent Technologies Deutschland GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jun 30, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 433 later devices descend from it.

Decided
Jun 30, 2000
Review
24 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 2 descendants cleared2003: 5 descendants cleared2002: 4 descendants cleared2006: 16 descendants cleared2010: 21 descendants cleared2011: 21 descendants cleared2005: 10 descendants cleared2008: 14 descendants cleared2004: 10 descendants cleared2007: 7 descendants cleared2009: 19 descendants cleared2012: 19 descendants cleared2014: 16 descendants cleared2013: 17 descendants cleared2015: 14 descendants cleared2017: 17 descendants cleared2016: 17 descendants cleared2018: 25 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2020: 14 descendants cleared2023: 27 descendants cleared2019: 17 descendants cleared2024: 25 descendants cleared200020052010201520202025
  1. This deviceK001722 Agilent Component Monitoring System; Agilent Invasive Blood Pressure…Agilent Technologies Deutschland GmbH · 2000
  2. Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  3. Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  4. Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  5. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  6. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002

Showing 5 of 433 descendants. See all descendants

Descendants cleared per year

2001: 22002: 42003: 52004: 102005: 102006: 162007: 72008: 142009: 192010: 212011: 212012: 192013: 172014: 162015: 142016: 172017: 172018: 252019: 172020: 142021: 192022: 282023: 272024: 252025: 292026: 20
2001high 29 (2025) · low 2 (2001)2026

Most influential descendants

Showing 5 of 433 · See all
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 2 generations on421descendants
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 2 generations on416descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001722Agilent Component Monitoring System; Agilent Invasive Blood Pressure ModuleAgilent Technologies Deutschland GmbH2000—
+1K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+2K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+2K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200240
200350
2004100
2005100
2006160
200770
2008140
2009190
2010210
2011210
2012190
2013170
2014160
2015140
2016170
2017170
2018250
2019170
2020140
2021190
2022280
2023270
2024250
2025290
2026200
FIG. 1 — Lineage of K001722, 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.

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? (433)

See all 433

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

NumberDeviceApplicantDecidedDescendants
K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc.2001431
K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors…Philips Medizin Systeme Boblingen GmbH20010

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, K013199 (Philips Medical Systems, Inc., 2001) has gone furthest, with 431 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 Deutschland GmbH

4 FDA decisions under this applicant name. See the company

  • K002758Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model…Agilent Technologies Deutschland GmbH · 2001
  • K003038Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model…Agilent Technologies Deutschland GmbH · 2000
  • K001333Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor…Agilent Technologies Deutschland GmbH · 2000

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https://510kreport.com/device/K001722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001722: Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001722

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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