510(k) Report

510(k) · Cleared

Cleared

ST/AR ST and Arrhythmia Software, Model Release D.0

K003621510(k) SpecialCleared Dec 20, 200026-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. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Dec 20, 2000 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 527 later devices descend from it.

Decided
Dec 20, 2000
Review
26 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

527 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2007: 9 descendants cleared2002: 7 descendants cleared2010: 23 descendants cleared2005: 12 descendants cleared2008: 16 descendants cleared2001: 1 descendant cleared2003: 5 descendants cleared2006: 16 descendants cleared2011: 27 descendants cleared2004: 10 descendants cleared2013: 18 descendants cleared2009: 21 descendants cleared2020: 21 descendants cleared2015: 19 descendants cleared2019: 24 descendants cleared2017: 22 descendants cleared2018: 28 descendants cleared2014: 19 descendants cleared2016: 20 descendants cleared2012: 20 descendants cleared2021: 23 descendants cleared2026: 29 descendants cleared2025: 38 descendants cleared2022: 34 descendants cleared2024: 34 descendants cleared2023: 31 descendants cleared200020052010201520202025
  1. This deviceK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent 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 · 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 527 descendants. See all descendants

Descendants cleared per year

2001: 12002: 72003: 52004: 102005: 122006: 162007: 92008: 162009: 212010: 232011: 272012: 202013: 182014: 192015: 192016: 202017: 222018: 282019: 242020: 212021: 232022: 342023: 312024: 342025: 382026: 29
2001high 38 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 527 · 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)K003621ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc.2000—
+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
200270
200350
2004100
2005120
2006160
200790
2008160
2009210
2010230
2011270
2012200
2013180
2014190
2015190
2016200
2017220
2018280
2019240
2020210
2021230
2022340
2023310
2024340
2025380
2026290
FIG. 1 — Lineage of K003621, 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 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? (527)

See all 527

10 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
K014261ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc.2002263
K021251ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems2002262
K013717Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp.200272
K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc.200571
K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc.200770
K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems200521
K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077
K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086
K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104

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—

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The MHX category page

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https://510kreport.com/device/K003621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003621: ST/AR ST and Arrhythmia Software, Model Release D.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003621

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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