510(k) Report

510(k) · Cleared

Cleared

Siemens Sirecust Penta System and Accessories

K920445510(k) TraditionalCleared Mar 2, 1993392-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 Electronics · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Mar 2, 1993 after a 392-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 300 later devices descend from it.

Decided
Mar 2, 1993
Review
392 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

300 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2002: 4 descendants cleared2003: 5 descendants cleared2004: 7 descendants cleared2005: 10 descendants cleared2012: 11 descendants cleared2009: 6 descendants cleared2022: 21 descendants cleared2006: 14 descendants cleared2010: 10 descendants cleared2024: 19 descendants cleared2011: 11 descendants cleared2007: 7 descendants cleared2016: 13 descendants cleared2015: 11 descendants cleared2013: 13 descendants cleared2017: 13 descendants cleared2008: 5 descendants cleared2018: 15 descendants cleared2026: 15 descendants cleared2014: 11 descendants cleared2021: 14 descendants cleared2020: 11 descendants cleared2019: 11 descendants cleared2023: 21 descendants cleared2025: 21 descendants cleared1990200020102020
  1. This deviceK920445 Siemens Sirecust Penta System and AccessoriesSiemens Medical Electronics · 1993
  2. Descendant · cites it directly · 299 of its ownK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
  3. Descendant · 2 generations on · 292 of its ownK013515 Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002
  4. Descendant · 3 generations on · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
  5. Descendant · 4 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
  6. Descendant · 5 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004

Showing 5 of 300 descendants. See all descendants

Descendants cleared per year

1996: 12002: 42003: 52004: 72005: 102006: 142007: 72008: 52009: 62010: 102011: 112012: 112013: 132014: 112015: 112016: 132017: 132018: 152019: 112020: 112021: 142022: 212023: 212024: 192025: 212026: 15
1996high 21 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 300 · See all
  • K955059Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996 · cites it directly299descendants
  • K013515Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on292descendants
  • K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · 3 generations on289descendants
  • K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 4 generations on280descendants
  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 5 generations on251descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920445Siemens Sirecust Penta System and AccessoriesSiemens Medical Electronics1993—
+1K955059Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc.1996—
+2K013515Infinity ExplorerSiemens Medical Solutions USA, Inc.2002—
+3K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…Siemens Medical Solutions USA, Inc.2002—
+4K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…Siemens Medical Solutions USA, Inc.2003—
+5K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200240
200350
200470
2005100
2006140
200770
200850
200960
2010100
2011110
2012110
2013130
2014110
2015110
2016130
2017130
2018150
2019110
2020110
2021140
2022210
2023210
2024190
2025210
2026150
FIG. 1 — Lineage of K920445, 1993–2026Source: 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? (300)

See all 300

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K955059Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc.1996299

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, K955059 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 299 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—

More from Siemens Medical Electronics

15 FDA decisions under this applicant name. See the company

  • K935043Siemens Clinical Work StationSiemens Medical Electronics · 1995
  • K921930Siemens Sirecust 700 Bedsides/Accessories, ModifiSiemens Medical Electronics · 1993
  • K914765Siemens NP Noninvasive Blood Press Measurement SysSiemens Medical Electronics · 1992
  • K912070Siemens Radiotom 904 & 904E Electrosurgery UnitSiemens Medical Electronics · 1992
  • K913489Siemens MICRO2 Pulse OximeterSiemens Medical Electronics · 1991

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https://510kreport.com/device/K920445 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920445: Siemens Sirecust Penta System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920445

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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