510(k) Report

510(k) · Cleared

Cleared

ST/AR ST and Arrhythmia Software

K001348510(k) SpecialCleared May 17, 200019-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 May 17, 2000 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 264 later devices descend from it.

Decided
May 17, 2000
Review
19 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

264 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 5 descendants cleared2010: 9 descendants cleared2008: 6 descendants cleared2002: 2 descendants cleared2004: 5 descendants cleared2016: 13 descendants cleared2015: 8 descendants cleared2005: 7 descendants cleared2006: 10 descendants cleared2009: 5 descendants cleared2011: 10 descendants cleared2012: 9 descendants cleared2013: 12 descendants cleared2017: 12 descendants cleared2018: 15 descendants cleared2014: 11 descendants cleared2021: 13 descendants cleared2020: 10 descendants cleared2023: 21 descendants cleared2022: 19 descendants cleared2019: 10 descendants cleared2025: 21 descendants cleared2024: 18 descendants cleared2026: 13 descendants cleared200020052010201520202025
  1. This deviceK001348 ST/AR ST and Arrhythmia SoftwareAgilent Technologies, Inc. · 2000
  2. Descendant · cites it directly · 263 of its ownK014261 ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc. · 2002
  3. Descendant · cites it directly · 262 of its ownK021251 ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems · 2002
  4. Descendant · 2 generations on · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
  5. Descendant · 3 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  6. Descendant · 3 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004

Showing 5 of 264 descendants. See all descendants

Descendants cleared per year

2002: 22004: 52005: 72006: 102007: 52008: 62009: 52010: 92011: 102012: 92013: 122014: 112015: 82016: 132017: 122018: 152019: 102020: 102021: 132022: 192023: 212024: 182025: 212026: 13
2002high 21 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 264 · See all
  • K014261ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc. · 2002 · cites it directly263descendants
  • K021251ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems · 2002 · cites it directly262descendants
  • K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc. · 2004 · 2 generations on260descendants
  • K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 3 generations on252descendants
  • K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 3 generations on251descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001348ST/AR ST and Arrhythmia SoftwareAgilent Technologies, Inc.2000—
+1K014261ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc.2002—
+1K021251ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems2002—
+2K040357M3290A Intellivue Information Center Software Release F.O and the M4840A…Philips Medical Systems, Inc.2004—
+3K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
+3K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200450
200570
2006100
200750
200860
200950
201090
2011100
201290
2013120
2014110
201580
2016130
2017120
2018150
2019100
2020100
2021130
2022190
2023210
2024180
2025210
2026130
FIG. 1 — Lineage of K001348, 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 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? (264)

See all 264

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

NumberDeviceApplicantDecidedDescendants
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
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, K014261 (Philips Medical Systems, Inc., 2002) has gone furthest, with 263 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/K001348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001348: ST/AR ST and Arrhythmia Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001348

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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