510(k) Report

510(k) · Cleared

Cleared

Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL

K003243510(k) SpecialCleared Dec 21, 200065-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

Siemens Medical Solutions USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Dec 21, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 291 later devices descend from it.

Decided
Dec 21, 2000
Review
65 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

291 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 6 descendants cleared2002: 1 descendant cleared2003: 4 descendants cleared2012: 11 descendants cleared2009: 6 descendants cleared2005: 9 descendants cleared2006: 14 descendants cleared2010: 10 descendants cleared2007: 7 descendants cleared2011: 11 descendants cleared2015: 11 descendants cleared2016: 13 descendants cleared2013: 13 descendants cleared2017: 13 descendants cleared2008: 5 descendants cleared2018: 15 descendants cleared2026: 15 descendants cleared2014: 11 descendants cleared2021: 14 descendants cleared2019: 11 descendants cleared2022: 20 descendants cleared2020: 11 descendants cleared2023: 21 descendants cleared2025: 21 descendants cleared2024: 18 descendants cleared200020052010201520202025
  1. This deviceK003243 Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XLSiemens Medical Solutions USA, Inc. · 2000
  2. Descendant · cites it directly · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
  3. Descendant · 2 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
  4. Descendant · 3 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
  5. Descendant · 4 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  6. Descendant · 5 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 291 descendants. See all descendants

Descendants cleared per year

2002: 12003: 42004: 62005: 92006: 142007: 72008: 52009: 62010: 102011: 112012: 112013: 132014: 112015: 112016: 132017: 132018: 152019: 112020: 112021: 142022: 202023: 212024: 182025: 212026: 15
2002high 21 (2023) · low 1 (2002)2026

Most influential descendants

Showing 5 of 291 · See all
  • K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · cites it directly289descendants
  • K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on280descendants
  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 3 generations on251descendants
  • K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on249descendants
  • K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 5 generations on247descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003243Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XLSiemens Medical Solutions USA, Inc.2000—
+1K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…Siemens Medical Solutions USA, Inc.2002—
+2K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…Siemens Medical Solutions USA, Inc.2003—
+3K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa2004—
+4K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
+5K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200340
200460
200590
2006140
200770
200850
200960
2010100
2011110
2012110
2013130
2014110
2015110
2016130
2017130
2018150
2019110
2020110
2021140
2022200
2023210
2024180
2025210
2026150
FIG. 1 — Lineage of K003243, 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
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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? (291)

See all 291

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

NumberDeviceApplicantDecidedDescendants
K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc.2002289
K033957Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC…Draeger Medical Systems, Inc.2004233
K033694Infinity Modular Monitors VF4 ModificationsDraeger Medical Systems, Inc.200437
K031433Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3…Siemens Medical Solutions USA, Inc.20030

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, K022889 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 289 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/K003243 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003243: Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003243

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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