510(k) Report

510(k) · Cleared

Cleared

Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact Portable Patient Monitor

K001057510(k) SpecialCleared May 3, 200030-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, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on May 3, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 470 later devices descend from it.

Decided
May 3, 2000
Review
30 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 6 descendants cleared2006: 17 descendants cleared2005: 11 descendants cleared2008: 17 descendants cleared2001: 1 descendant cleared2010: 24 descendants cleared2004: 10 descendants cleared2003: 5 descendants cleared2011: 26 descendants cleared2013: 18 descendants cleared2009: 20 descendants cleared2014: 19 descendants cleared2007: 8 descendants cleared2012: 21 descendants cleared2015: 16 descendants cleared2016: 19 descendants cleared2017: 20 descendants cleared2018: 26 descendants cleared2025: 29 descendants cleared2026: 22 descendants cleared2021: 20 descendants cleared2022: 28 descendants cleared2019: 18 descendants cleared2020: 16 descendants cleared2023: 27 descendants cleared2024: 26 descendants cleared200020052010201520202025
  1. This deviceK001057 Agilent Information Center Software for M3150A and M3153A and…Agilent Technologies, Inc. · 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 · cites it directly · 426 of its ownK021422 Philips Information Center Software Revision D.02Philips Medical Systems · 2002
  4. Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  5. Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  6. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002

Showing 5 of 470 descendants. See all descendants

Descendants cleared per year

2001: 12002: 62003: 52004: 102005: 112006: 172007: 82008: 172009: 202010: 242011: 262012: 212013: 182014: 192015: 162016: 192017: 202018: 262019: 182020: 162021: 202022: 282023: 272024: 262025: 292026: 22
2001high 29 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 470 · See all
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
  • K021422Philips Information Center Software Revision D.02Philips Medical Systems · 2002 · cites it directly426descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001057Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4…Agilent Technologies, Inc.2000—
+1K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+1K021422Philips Information Center Software Revision D.02Philips Medical Systems2002—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200260
200350
2004100
2005110
2006170
200780
2008170
2009200
2010240
2011260
2012210
2013180
2014190
2015160
2016190
2017200
2018260
2019180
2020160
2021200
2022280
2023270
2024260
2025290
2026220
FIG. 1 — Lineage of K001057, 2000–2026Source: 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? (470)

See all 470

7 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
K021422Philips Information Center Software Revision D.02Philips Medical Systems2002426
K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems200521
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)

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 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, Inc.

105 FDA decisions under this applicant name. See the company

  • P230016/S004MAGE-A4 IHC 1F9 pharmDxAgilent Technologies, Inc. · 2026
  • P150013/S034PD-L1 IHC 22C3 pharmDxAgilent Technologies, Inc. · 2026
  • P150025/S019PD-L1 IHC 28-8 pharmDxAgilent Technologies, Inc. · 2026
  • P230016/S003MAGE-A4 IHC 1F9 pharmDxAgilent Technologies, Inc. · 2026
  • P150025/S020PD-L1 IHC 28-8 pharmDxAgilent Technologies, Inc. · 2026

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/K001057 · printed Nov 3, 2026

Cite this page

510(k) Report. “K001057: Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact Portable Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001057

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