510(k) Report

510(k) · Cleared

Cleared

Siemens Medical Information Bus (Mib) Protocol Converter

K003248510(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. 41 later devices descend from it.

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

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

Descendants, by year cleared 2004: 1 descendant cleared2002: 2 descendants cleared2001: 1 descendant cleared2005: 2 descendants cleared2007: 2 descendants cleared2006: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2021: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2020: 3 descendants cleared2023: 4 descendants cleared2026: 3 descendants cleared2024: 6 descendants cleared2025: 3 descendants cleared200020052010201520202025
  1. This deviceK003248 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2000
  2. Descendant · cites it directly · 40 of its ownK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
  3. Descendant · cites it directly · 39 of its ownK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
  4. Descendant · cites it directly · 38 of its ownK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
  5. Descendant · cites it directly · 37 of its ownK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
  6. Descendant · 2 generations on · 36 of its ownK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22004: 12005: 22006: 12007: 22010: 12012: 12013: 12015: 22018: 12019: 22020: 32021: 22022: 32023: 42024: 62025: 32026: 3
2001high 6 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 41 · See all
  • K012461Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001 · cites it directly40descendants
  • K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002 · cites it directly39descendants
  • K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002 · cites it directly38descendants
  • K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc. · 2004 · cites it directly37descendants
  • K043439Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X…Draeger Medical Systems, Inc. · 2005 · 2 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003248Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc.2000—
+1K012461Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc.2001—
+1K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc.2002—
+1K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc.2002—
+1K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc.2004—
+2K043439Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista…Draeger Medical Systems, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200410
200520
200610
200720
201010
201210
201310
201520
201810
201920
202030
202120
202230
202340
202460
202530
202630
FIG. 1 — Lineage of K003248, 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? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K012461Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc.200140
K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc.200239
K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc.200238
K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc.200437

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, K012461 (Siemens Medical Solutions USA, Inc., 2001) has gone furthest, with 40 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/K003248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003248: Siemens Medical Information Bus (Mib) Protocol Converter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003248

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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