510(k) Report

510(k) · Cleared

Cleared

Siemens Medical Information Bus (Mib II) Protocol Converter

K010640510(k) SpecialCleared Mar 20, 200115-day reviewClass II21 CFR 870.2060

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. · DRQ Amplifier And Signal Conditioner, Transducer Signal

Cleared on Mar 20, 2001 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.

Decided
Mar 20, 2001
Review
15 days
Class
Class II
Product code
DRQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 2 descendants cleared2004: 1 descendant cleared2002: 2 descendants cleared2005: 3 descendants cleared2006: 1 descendant cleared2007: 2 descendants 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 deviceK010640 Siemens Medical Information Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
  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 43 descendants. See all descendants

Descendants cleared per year

2001: 22002: 22004: 12005: 32006: 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 43 · 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)K010640Siemens Medical Information Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc.2001—
+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
200120
200220
200410
200530
200610
200720
201010
201210
201310
201520
201810
201920
202030
202120
202230
202340
202460
202530
202630
FIG. 1 — Lineage of K010640, 2001–2026Source: 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 DRQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (43)

See all 43

5 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
K012016Infinity SC 8000 with Advanced Communication Option IISiemens Medical Solutions USA, Inc.200129

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 DRQ devices

DRQ Amplifier And Signal Conditioner, Transducer Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRQ

1in 2017

2015: 22017: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRQ

Too few DRQ 510(k)s in any year since 2007 to give a median.

Recalls per year · DRQ

No recall names DRQ since 2007.

Adverse event reports per year · DRQ

3in 2025

2015: 12016: 22017: 32018: 12020: 52021: 42022: 62023: 82024: 52025: 3
2007high 8 (2023) · low 0 (2007)2025

MAUDE reports naming product code DRQ, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20152—01
20160—02
20171—03
20180—01
20190—00
20200—05
20210—04
20220—06
20230—08
20240—05
20250—03
20260—0—

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Recent decisions in DRQ

The DRQ category page

  • K172216ACIST RXi Mini SystemAcist Medical Systems, Inc. · 2017
  • K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels…Boston Scientific Corporation · 2015
  • K150235CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120…Boston Scientific Corporation · 20151 recall
  • K050006Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40…C.R. Bard, Inc. · 2005
  • K050974Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol ConvertersDraeger Medical Systems, Inc. · 2005

https://510kreport.com/device/K010640 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010640: Siemens Medical Information Bus (Mib II) 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/K010640

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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