510(k) Report

510(k) · Cleared

Cleared

Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor

K000822510(k) SpecialCleared Apr 6, 200023-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, GmbH · DSI Detector And Alarm, Arrhythmia

Cleared on Apr 6, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 462 later devices descend from it.

Decided
Apr 6, 2000
Review
23 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

462 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2005: 13 descendants cleared2010: 25 descendants cleared2004: 12 descendants cleared2001: 1 descendant cleared2003: 5 descendants cleared2002: 4 descendants cleared2006: 17 descendants cleared2011: 26 descendants cleared2007: 7 descendants cleared2009: 20 descendants cleared2013: 18 descendants cleared2008: 16 descendants cleared2015: 16 descendants cleared2018: 25 descendants cleared2017: 19 descendants cleared2016: 20 descendants cleared2012: 20 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2014: 17 descendants cleared2019: 18 descendants cleared2020: 14 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2024: 26 descendants cleared2023: 27 descendants cleared200020052010201520202025
  1. This deviceK000822 Agilentcomponent Monitoring System, Agilent 24/26, Agilent…Agilent Technologies, 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 462 descendants. See all descendants

Descendants cleared per year

2001: 12002: 42003: 52004: 122005: 132006: 172007: 72008: 162009: 202010: 252011: 262012: 202013: 182014: 172015: 162016: 202017: 192018: 252019: 182020: 142021: 192022: 282023: 272024: 262025: 292026: 20
2001high 29 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 462 · 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)K000822Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement…Agilent Technologies, 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
200110
200240
200350
2004120
2005130
2006170
200770
2008160
2009200
2010250
2011260
2012200
2013180
2014170
2015160
2016200
2017190
2018250
2019180
2020140
2021190
2022280
2023270
2024260
2025290
2026200
FIG. 1 — Lineage of K000822, 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 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
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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? (462)

See all 462

6 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
K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc.200488
K042306Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH200476
K052377Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH200542
K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022
K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems200521

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, GmbH

2 FDA decisions under this applicant name. See the company

  • K994188Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5Agilent Technologies, GmbH · 2000

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The DSI category page

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  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
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https://510kreport.com/device/K000822 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000822: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000822

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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