510(k) Report

510(k) · Cleared

Cleared

Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model M1175A/76A/77A,Rev.L,M1205A,Rev.L,M1034A

K003038510(k) TraditionalCleared Dec 15, 200077-day reviewClass II21 CFR 882.1400

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 · OLW Index-Generating Electroencephalograph Software

Cleared on Dec 15, 2000 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 409 later devices descend from it.

Decided
Dec 15, 2000
Review
77 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 3 descendants cleared2005: 9 descendants cleared2006: 14 descendants cleared2004: 9 descendants cleared2007: 6 descendants cleared2010: 20 descendants cleared2009: 15 descendants cleared2003: 4 descendants cleared2011: 19 descendants cleared2012: 19 descendants cleared2008: 14 descendants cleared2015: 14 descendants cleared2013: 17 descendants cleared2016: 16 descendants cleared2017: 17 descendants cleared2018: 25 descendants cleared2014: 14 descendants cleared2021: 18 descendants cleared2020: 14 descendants cleared2023: 26 descendants cleared2022: 28 descendants cleared2019: 17 descendants cleared2025: 28 descendants cleared2024: 24 descendants cleared2026: 19 descendants cleared200020052010201520202025
  1. This deviceK003038 Agilent Component Monitoring System, Agilent V24/26, Agilent Bis…Agilent Technologies Deutschland GmbH · 2000
  2. Descendant · cites it directly · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  3. Descendant · 2 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  4. Descendant · 2 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  5. Descendant · 2 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  6. Descendant · 2 generations on · 375 of its ownK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003

Showing 5 of 409 descendants. See all descendants

Descendants cleared per year

2002: 32003: 42004: 92005: 92006: 142007: 62008: 142009: 152010: 202011: 192012: 192013: 172014: 142015: 142016: 162017: 172018: 252019: 172020: 142021: 182022: 282023: 262024: 242025: 282026: 19
2002high 28 (2022) · low 3 (2002)2026

Most influential descendants

Showing 5 of 409 · See all
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · cites it directly407descendants
  • K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 2 generations on406descendants
  • K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 2 generations on404descendants
  • K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 2 generations on376descendants
  • K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH · 2003 · 2 generations on375descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003038Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model…Agilent Technologies Deutschland GmbH2000—
+1K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+2K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
+2K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
+2K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
+2K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200340
200490
200590
2006140
200760
2008140
2009150
2010200
2011190
2012190
2013170
2014140
2015140
2016160
2017170
2018250
2019170
2020140
2021180
2022280
2023260
2024240
2025280
2026190
FIG. 1 — Lineage of K003038, 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 OLW? 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 OLW device

  1. #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 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? (409)

See all 409

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

NumberDeviceApplicantDecidedDescendants
K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002407
K014159Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient MonitorPhilips Medical Systems, Inc.2002253

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, K021778 (Philips Medical Systems, 2002) has gone furthest, with 407 descendants of its own.

How does its category compare?

All OLW devices

OLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLW

1in 2024

2007: 32008: 22015: 12018: 12021: 12022: 12023: 12024: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLW

105in 2007

2007: 105 days median
2007high 105 (2007)2026

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

Recalls per year · OLW

No recall names OLW since 2007.

Adverse event reports per year · OLW

73in 2025

2017: 32018: 32019: 62020: 152021: 152022: 272023: 182024: 932025: 73
2007high 93 (2024) · low 0 (2007)2025

MAUDE reports naming product code OLW, 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
2007310500
20082—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—03
20181—03
20190—06
20200—015
20211—015
20221—027
20231—018
20241—093
20250—073
20262—0—

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
  • 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 OLW

The OLW category page

  • K260907BIS™ Advance pEEG ModuleCovidien LP · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K230693BIS™ Advance Monitoring SystemCovidien, LLC · 2024
  • K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd. · 2023
  • K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation · 2022

https://510kreport.com/device/K003038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003038: Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model M1175A/76A/77A,Rev.L,M1205A,Rev.L,M1034A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003038

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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