510(k) · Cleared
ClearedInfinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · DRQ Amplifier And Signal Conditioner, Transducer Signal
Cleared on Mar 9, 2004 as substantially equivalent to K022766 (Siemens Medical Solutions USA, Inc., 2002) and 8 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1992. 37 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 92 days
- Class
- Class II
- Product code
- DRQ
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K923682 (1992). 10 ancestors in all. 37 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 5 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 4 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 3 generations backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- 2 generations backK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
- This deviceK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- Descendant · cites it directly · 36 of its ownK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 32 of its ownK051658 Infinity AlphaDraeger Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 26 of its ownK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 26 of its ownK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K043439Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X…Draeger Medical Systems, Inc. · 2005 · cites it directly36descendants
- K051658Infinity AlphaDraeger Medical Systems, Inc. · 2005 · 2 generations on32descendants
- K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · 2 generations on27descendants
- K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007 · 2 generations on26descendants
- K061379Infinity Telesmart Telemetry SystemDraeger 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 |
|---|---|---|---|---|---|
| −6 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −5 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −4 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −3 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter | Draeger Medical Systems, Inc. | 2004 | — |
| +1 | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista… | Draeger Medical Systems, Inc. | 2005 | — |
| +2 | K051658 | Infinity Alpha | Draeger Medical Systems, Inc. | 2005 | — |
| +2 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +2 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| +3 | K061379 | Infinity Telesmart Telemetry System | Draeger Medical Systems, Inc. | 2007 | — |
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 |
|---|---|---|
| 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? (9)
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 |
|---|---|---|---|
| * | K022766 | Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSummary page 1…Number Transducer Signal amplifi er and conditioner 73 DRQ II 21 CFR 870.2060 Legally Marketed Device Identification: INFINITY MIB/MIB II / MIB DUO (K022766) INFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Pr… | 2002 |
| * | K012461 | Siemens Infinity Mib II Duo Protocol ConverterSummary page 1…and conditioner 73 DRQ II 21 CFR 870.2060 Legally Marketed Device Identification: INFINITY MIB/MIB II / MIB DUO (K022766) INFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K97… | 2001 |
| * | K010640 | Siemens Medical Information Bus (Mib II) Protocol ConverterSummary page 1…Legally Marketed Device Identification: INFINITY MIB/MIB II / MIB DUO (K022766) INFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY N… | 2001 |
| * | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSummary page 1…DUO (K022766) INFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246) Description of Modification:… | 1997 |
| * | K973222 | SC9000/SC9015 Medical Information Bus (Mib) Protocol ConverterSummary page 1…766) INFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246) Description of Modification: Draeger'… | 1997 |
| * | K991661 | Siemens Medical Information Bus (Mib) Protocol ConverterSummary page 1…NFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246) Description of Modification: Draeger's Infinit… | 1999 |
| * | K003248 | Siemens Medical Information Bus (Mib) Protocol ConverterSummary page 1…IB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246) Description of Modification: Draeger's Infinity Medical… | 2000 |
| * | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol ConverterSummary page 1…: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246) Description of Modification: Draeger's Infinity Medical Informat… | 2002 |
| * | K003246 | Siemens Multi View Workstation with Vent Viewer OptionSummary page 1…K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246) Description of Modification: Draeger's Infinity Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters have receiv… | 2000 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X… | 2005 | 36 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K043439 (Draeger Medical Systems, Inc., 2005) has gone furthest, with 36 descendants of its own.
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 Infinity Medical Information Bus (MIB) Protocol Converters (MIB, H & 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 Draeger INF1IITY Modular Monitor for display. Such devices include: Maquet SV 300 ventilator Maquet Se~rvoi Ventilator Maquet SV900…
Read the full statement (210 words)
The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, H & 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 Draeger INF1IITY Modular Monitor for display. Such devices include:
Maquet SV 300 ventilator
Maquet Se~rvoi Ventilator
Maquet SV900 ventilator
Draeger Evita 2 ventilator
Draeger Evita 4 ventilator
Draeger EvitaXL ventilator
Draeger Savina ventilator
Draeger Babylog ventilator
Draeger FabiusGS Anesthesia System
Draeger Narkomed 2 Anesthesia System
Draeger Narkomed 4 Anesthesia System
Draeger Narkomed 6000 / 6400 Anesthesia Systems.
Draeger Julian Anesthesia Machine
Puritan Bennett 7200 ventilator
Puritan Bennett 840 ventilator
Hamilton Galileo ventilator
Ohmeda 7900 Anesthesia Machine
Abbott Oximetrix 3 Blood Gas Analyzer
Abbott Q2 CCO monitor
AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer
Baxter Vigilance blood gas/continuous cardiac output monitor
Optical Sensors Inc.: OSI - Optical CAM
VIA Medical: VIA V-ABGl Blood Gas Chemistry Monitor
Aspect A-2000 BIS Monitor*
Sensormedics Micro Gas 7650
Note: *The SC 9000 does no': support communication with the Aspect BIS Monitor
MMI Compatibility Statement:
The MIB, MIB II and MIB DUO Protocol Converters are not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033807: Infinityedical Information Bus (Mib/Mib II and Mib Duo) 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/K033807
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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