510(k) Report

510(k) · Cleared

Cleared

GE Marquette Ecg Analysis Program

K002209510(k) SpecialCleared Aug 18, 200028-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

General Electric Medical Systems Information Techn · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 18, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 87 later devices descend from it.

Decided
Aug 18, 2000
Review
28 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

87 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 3 descendants cleared2006: 2 descendants cleared2011: 7 descendants cleared2012: 3 descendants cleared2009: 5 descendants cleared2010: 6 descendants cleared2008: 3 descendants cleared2014: 9 descendants cleared2004: 1 descendant cleared2013: 6 descendants cleared2015: 4 descendants cleared2017: 4 descendants cleared2016: 7 descendants cleared2023: 3 descendants cleared2018: 5 descendants cleared2024: 6 descendants cleared2020: 3 descendants cleared2022: 4 descendants cleared2021: 1 descendant cleared2025: 2 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK002209 GE Marquette Ecg Analysis ProgramGeneral Electric Medical Systems Information Techn · 2000
  2. Descendant · cites it directly · 71 of its ownK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
  3. Descendant · 2 generations on · 32 of its ownK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
  4. Descendant · 2 generations on · 31 of its ownK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
  5. Descendant · 3 generations on · 30 of its ownK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
  6. Descendant · cites it directly · 30 of its ownK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

2002: 12003: 32004: 12006: 22008: 32009: 52010: 62011: 72012: 32013: 62014: 92015: 42016: 72017: 42018: 52020: 32021: 12022: 42023: 32024: 62025: 22026: 2
2002high 9 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 87 · See all
  • K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002 · cites it directly71descendants
  • K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc. · 2009 · 2 generations on32descendants
  • K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003 · 2 generations on31descendants
  • K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004 · 3 generations on30descendants
  • K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003 · cites it directly30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002209GE Marquette Ecg Analysis ProgramGeneral Electric Medical Systems Information Techn2000—
+1K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn2002—
+2K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6…Edan Instruments, Inc.20091
+2K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies2003—
+3K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies2004—
+1K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200330
200410
200620
200830
200950
201060
201170
201230
201360
201490
201540
201670
201740
201850
202030
202110
202240
202330
202460
202520
202620
FIG. 1 — Lineage of K002209, 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? (87)

See all 87

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

NumberDeviceApplicantDecidedDescendants
K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn200271
K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies200330
K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies200621

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, K014108 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 71 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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https://510kreport.com/device/K002209 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002209: GE Marquette Ecg Analysis Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002209

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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