510(k) · Cleared
ClearedSiemens Medical Information Bus (Mib) Protocol Converter
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 May 28, 1999 as substantially equivalent to K970368 (Siemens Medical Solutions USA, Inc., 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1992. 41 later devices descend from it.
- Decided
- May 28, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923682 (1992). 3 ancestors in all. 41 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 1 generation backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- This deviceK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 40 of its ownK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 39 of its ownK020277 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
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −1 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 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 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? (2)
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 |
|---|---|---|---|
| * | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSummary page 1…ducer Signal amplifier and conditioner 73 DQA I 21 CFR 870.2060 Legally Marketed Device Identification: Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368 and K973222. Description of Modification: The Medical Information Bus (MIB) Protocol Converter has received two 510(k) clearance… | 1997 |
| * | K973222 | SC9000/SC9015 Medical Information Bus (Mib) Protocol ConverterSummary page 1…amplifier and conditioner 73 DQA I 21 CFR 870.2060 Legally Marketed Device Identification: Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368 and K973222. Description of Modification: The Medical Information Bus (MIB) Protocol Converter has received two 510(k) clearances. 1. 510(k… | 1997 |
What descends from it? (41)
See all 414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012461 | Siemens Infinity Mib II Duo Protocol Converter | 2001 | 40 |
| K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | 2002 | 39 |
| K022766 | Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter | 2002 | 38 |
| 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 7 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K012461 (Siemens Medical Solutions USA, Inc., 2001) has gone furthest, with 40 descendants of its own.
- 4 other devices also cite its predicate K970368.
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 Converter is 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 do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to the Siemens INFINITY Modular Bedside Monitors for display, such as: Siemens SV 300 ventilator Baxter…
Read the full statement (141 words)
The Medical Information Bus (MIB) Protocol Converter is 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 do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to the Siemens INFINITY Modular Bedside Monitors for display, such as:
Siemens SV 300 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 II Anesthesia System
Draeger Narkomed IV Anesthesia System
Draeger Julian Anesthesia Machine
Ohmeda 7900 / Modulus CD Anesthesia Machine
Abbott Oximetrix 3 Oximeter
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
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/K991661 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991661: Siemens Medical Information Bus (Mib) Protocol Converter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991661
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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