510(k) · Cleared
ClearedSiemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DQA Oximeter
Cleared on Sep 5, 2002 as substantially equivalent to K012461 (Siemens Medical Solutions USA, Inc., 2001) and 7 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1992. 38 later devices descend from it.
- Decided
- Sep 5, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K923682 (1992). 9 ancestors in all. 38 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 4 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 3 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 2 generations backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- 1 generation backK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- This deviceK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 37 of its ownK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 36 of its ownK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 32 of its ownK051658 Infinity AlphaDraeger Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 26 of its ownK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- 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
- K051658Infinity AlphaDraeger Medical Systems, Inc. · 2005 · 3 generations on32descendants
- K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · 3 generations on27descendants
- K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −4 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −2 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −1 | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K022766 | Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter | Draeger Medical Systems, Inc. | 2004 | — |
| +2 | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista… | Draeger Medical Systems, Inc. | 2005 | — |
| +3 | K051658 | Infinity Alpha | Draeger Medical Systems, Inc. | 2005 | — |
| +3 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +3 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012461 | Siemens Infinity Mib II Duo Protocol Converter | 2001 |
| * | K010640 | Siemens Medical Information Bus (Mib II) Protocol Converter | 2001 |
| * | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSummary page 1…Duo: 5 1O(k) KO 12461 Siemens INFINITY MIB I1 Protocol Converter: 5 10(k) KO10640 Siemens Medical Information Bus (MIB) Protocol Converter: 5 10(k) K970368, K973222, K99 1661, K003248, KO20277 Siemens MVWS and INFINITY Network with INFINITY… | 1997 |
| * | K973222 | SC9000/SC9015 Medical Information Bus (Mib) Protocol ConverterSummary page 1…O(k) KO 12461 Siemens INFINITY MIB I1 Protocol Converter: 5 10(k) KO10640 Siemens Medical Information Bus (MIB) Protocol Converter: 5 10(k) K970368, K973222, K99 1661, K003248, KO20277 Siemens MVWS and INFINITY Network with INFINITY… | 1997 |
| * | K991661 | Siemens Medical Information Bus (Mib) Protocol ConverterSummary page 1…2461 Siemens INFINITY MIB I1 Protocol Converter: 5 10(k) KO10640 Siemens Medical Information Bus (MIB) Protocol Converter: 5 10(k) K970368, K973222, K99 1661, K003248, KO20277 Siemens MVWS and INFINITY Network with INFINITY… | 1999 |
| * | K003248 | Siemens Medical Information Bus (Mib) Protocol ConverterSummary page 1…Siemens INFINITY MIB I1 Protocol Converter: 5 10(k) KO10640 Siemens Medical Information Bus (MIB) Protocol Converter: 5 10(k) K970368, K973222, K99 1661, K003248, KO20277 Siemens MVWS and INFINITY Network with INFINITY Ve… | 2000 |
| * | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | 2002 |
| * | K003246 | Siemens Multi View Workstation with Vent Viewer OptionSummary page 1…68, K973222, K99 1661, K003248, KO20277 Siemens MVWS and INFINITY Network with INFINITY Ventviewer (K003246) Description of Modification: Siemens Medical Information Bus (MIB) Protocol Converters have received numerous 5 1 O(k)… | 2000 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter | 2004 | 37 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K033807 (Draeger Medical Systems, Inc., 2004) has gone furthest, with 37 descendants of its own.
- 2 other devices also cite its predicate K012461.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Medical Information Bus (MIB) Protocol Converters (MIB, I1 & MIB Duo) are indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that provide data should be connected to a Siemens INFINITY Modular Bedside Monitor (SC 9000 / SC 7000 / SC 8000 / SC 9000XL) for display. Such devices include: Siemens SV 300 ventilator…
Read the full statement (180 words)
The Medical Information Bus (MIB) Protocol Converters (MIB, I1 & MIB Duo) are indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that provide data should be connected to a Siemens INFINITY Modular Bedside Monitor (SC 9000 / SC 7000 / SC 8000 / SC 9000XL) for display. Such devices include:
Siemens SV 300 ventilator
Siemens Servoi ventilator
Baxter Vigilance blood gas/CCO monitor
Siemens SV900 ventilator
Draeger Evita I1 ventilator
Draeger Evita IV ventilator
Draeger Babylog ventilator
Puritan Bennett 7200 ventilator
Puritan Bennett 840 ventilator
Hamilton Galileo ventilator
Draeger Narkomed I1 Anesthesia System
Draeger Narkomed IV Anesthesia System
Draeger Julian Anesthesia Machine
Ohmeda 7900 Anesthesia Machine
Abbott Oxirnetrix 3 Blood Gas Analyzer
Abbott Q2 CCO monitor
AVL Medical Instruments: Opt1 Critical Care Analyzer, Portable Blood Gas Analyzer
Optical Sensors Inc.: OS1 - Optical CAM
VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor
Aspect A-2000 BIS Monitor*
Sensormedics Micro Gas 7650
Note: "The SC 9000 does not support coinmunication with the Aspect BIS Monitor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022766: Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022766
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026