510(k) · Cleared
ClearedSiemens Medical Infromation Bus (Mib II) Protocol Converter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DRQ Amplifier And Signal Conditioner, Transducer Signal
Cleared on Feb 19, 2002 as substantially equivalent to K012461 (Siemens Medical Solutions USA, Inc., 2001) and 6 other predicates after a 22-day review. Its family tree reaches back 4 generations to 1992. 39 later devices descend from it.
- Decided
- Feb 19, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- DRQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K923682 (1992). 8 ancestors in all. 39 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 3 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 2 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 1 generation backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- This deviceK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 38 of its ownK022766 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
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- 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
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −3 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −1 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| 0 (this device) | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | 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 |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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 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
What was it cleared against? (7)
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 ConverterSummary page 1…ulation Number Number Transducer Signal amplifier and conditioner | 73 DRQ I 21 CFR 870.2060 Legally Marketed Device Identification: Siemens INFINITY MIB II Duo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K9703… | 2001 |
| * | K010640 | Siemens Medical Information Bus (Mib II) Protocol ConverterSummary page 1…tioner | 73 DRQ I 21 CFR 870.2060 Legally Marketed Device Identification: Siemens INFINITY MIB II Duo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248 Siemens MVWS and INFINITY Net… | 2001 |
| * | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSummary page 1…: Siemens INFINITY MIB II Duo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248 Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246) 4 Description of Modification:… | 1997 |
| * | K973222 | SC9000/SC9015 Medical Information Bus (Mib) Protocol ConverterSummary page 1…INFINITY MIB II Duo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248 Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246) 4 Description of Modification: The Medic… | 1997 |
| * | K991661 | Siemens Medical Information Bus (Mib) Protocol ConverterSummary page 1…MIB II Duo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248 Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246) 4 Description of Modification: The Medical Inform… | 1999 |
| * | K003248 | Siemens Medical Information Bus (Mib) Protocol ConverterSummary page 1…uo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248 Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246) 4 Description of Modification: The Medical Information Bus… | 2000 |
| * | K003246 | Siemens Multi View Workstation with Vent Viewer OptionSummary page 1…) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248 Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246) 4 Description of Modification: The Medical Information Bus (MIB) Protocol Converters have received six 510(k) clearances for… | 2000 |
What descends from it? (39)
See all 392 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K022766 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 38 descendants of its own.
- 2 other devices also cite its predicate K012461.
How does its category compare?
All DRQ devicesDRQ 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
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
MAUDE reports naming product code DRQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medical Information Bus (MIB) Protocol Converters (MIB, I & 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, such as: Siemens SV 300 ventilator Siemens Servoi ventilator Baxter Vigilance blood gas/continuous cardiac output monitor Siemens SV900 ventilator Draeger Evita II…
Read the full statement (187 words)
The Medical Information Bus (MIB) Protocol Converters (MIB, I & 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, such as:
Siemens SV 300 ventilator
Siemens Servoi ventilator
Baxter Vigilance blood gas/continuous cardiac output monitor
Siemens SV900 ventilator
Draeger Evita II ventilator
Draeger Evita IV ventilator
Draeger Babylog ventilator
Puritan Bennett 7200 ventilator
Draeger Narkomed I1 Anesthesia System
Draeger Narkomed 1V Anesthesia System
Draeger Julian Anesthesia Machine
Ohmeda 7900 Anesthesia Machine
Abbott Oximetrix 3 Blood Gas Analyzer
AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer
Optical Sensors Inc.: OSI— Optical CAM
VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
Aspect A-2000 BIS Monitor
should be connected to a Siemens INFINITY Modular Bedside Monitor (SC 9000 / SC 7000 / SC 8000 / SC 9000XL) for display.
Note: *The SC 9000 does not support communication with the Aspect BIS Monitor
MRI Compatibility Statement:
The MIB, MIB II and MIB DUO Protocol Converters are not compatible for use in a MRI magnetic field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020277: Siemens Medical Infromation 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/K020277
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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