510(k) Report

510(k) · Cleared

Cleared

Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A

K002758510(k) TraditionalCleared Feb 22, 2001170-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 · DSI Detector And Alarm, Arrhythmia

Cleared on Feb 22, 2001 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 158 later devices descend from it.

Decided
Feb 22, 2001
Review
170 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2003: 1 descendant cleared2007: 2 descendants cleared2012: 8 descendants cleared2009: 5 descendants cleared2011: 6 descendants cleared2008: 2 descendants cleared2010: 5 descendants cleared2017: 9 descendants cleared2013: 9 descendants cleared2015: 7 descendants cleared2014: 9 descendants cleared2016: 9 descendants cleared2021: 6 descendants cleared2018: 10 descendants cleared2019: 6 descendants cleared2023: 11 descendants cleared2020: 6 descendants cleared2022: 13 descendants cleared2025: 15 descendants cleared2026: 7 descendants cleared2024: 11 descendants cleared200020052010201520202025
  1. This deviceK002758 Agilent Component Monitoring System, Agilent Cardiac Output Module…Agilent Technologies Deutschland GmbH · 2001
  2. Descendant · cites it directly · 156 of its ownK033444 Philips Medical Systems, M3012A- Hemodynamic Extension to the…Philips Medical Systems · 2003
  3. Descendant · 2 generations on · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  4. Descendant · 2 generations on · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
  5. Descendant · 2 generations on · 125 of its ownK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  6. Descendant · 2 generations on · 124 of its ownK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009

Showing 5 of 158 descendants. See all descendants

Descendants cleared per year

2001: 12003: 12007: 22008: 22009: 52010: 52011: 62012: 82013: 92014: 92015: 72016: 92017: 92018: 102019: 62020: 62021: 62022: 132023: 112024: 112025: 152026: 7
2001high 15 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 158 · See all
  • K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems · 2003 · cites it directly156descendants
  • K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on151descendants
  • K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · 2 generations on127descendants
  • K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · 2 generations on125descendants
  • K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · 2 generations on124descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002758Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent…Agilent Technologies Deutschland GmbH2001—
+1K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the…Philips Medical Systems2003—
+2K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+2K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083
+2K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
+2K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200720
200820
200950
201050
201160
201280
201390
201490
201570
201690
201790
2018100
201960
202060
202160
2022130
2023110
2024110
2025150
202670
FIG. 1 — Lineage of K002758, 2001–2026Source: 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.

Planning a device in DSI? 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 DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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? (158)

See all 158

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

NumberDeviceApplicantDecidedDescendants
K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems2003156
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, K033444 (Philips Medical Systems, 2003) has gone furthest, with 156 descendants of its own.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

More from Agilent Technologies Deutschland GmbH

4 FDA decisions under this applicant name. See the company

  • K003038Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model…Agilent Technologies Deutschland GmbH · 2000
  • K001722Agilent Component Monitoring System; Agilent Invasive Blood Pressure ModuleAgilent Technologies Deutschland GmbH · 2000
  • K001333Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor…Agilent Technologies Deutschland GmbH · 2000

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K002758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002758: Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002758

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