510(k) Report

510(k) · Cleared

Cleared

Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol Converters

K050974510(k) SpecialCleared Apr 29, 200511-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

Draeger Medical Systems, Inc. · DRQ Amplifier And Signal Conditioner, Transducer Signal

Cleared on Apr 29, 2005 after an 11-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.

Decided
Apr 29, 2005
Review
11 days
Class
Class II
Product code
DRQ
Recalls
None
Predicates
0

28 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2021: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2020: 1 descendant cleared2026: 3 descendants cleared2024: 5 descendants cleared2023: 3 descendants cleared2025: 3 descendants cleared20052010201520202025
  1. This deviceK050974 Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2005
  2. Descendant · cites it directly · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
  3. 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
  4. Descendant · 3 generations on · 24 of its ownK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · Recalled
  5. Descendant · 4 generations on · 23 of its ownK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
  6. Descendant · 5 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12010: 12012: 12015: 12018: 12019: 22020: 12021: 22022: 32023: 32024: 52025: 32026: 3
2006high 5 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 28 · See all
  • K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · cites it directly27descendants
  • K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007 · 2 generations on26descendants
  • K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · 3 generations on24descendants
  • K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · 4 generations on23descendants
  • K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 5 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050974Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol ConvertersDraeger Medical Systems, Inc.2005—
+1K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc.20061
+2K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc.20076
+3K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc.20104
+4K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.20128
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple…Snap40, Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201010
201210
201510
201810
201920
202010
202120
202230
202330
202450
202530
202630
FIG. 1 — Lineage of K050974, 2005–2026Source: 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), 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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Infinity Medical Information Bus Protocol Converter
Named without a submission number
—

What descends from it? (28)

See all 28

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc.200627

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, K060039 (Draeger Medical Systems, Inc., 2006) has gone furthest, with 27 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—

What is it indicated for?

The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, II & 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 Infinity Modular Monitor for display. Such devices include: Maquet SV 300 ventilator Maquet Servoi Ventilator Maquet SV900…

Read the full statement (182 words)

The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, II & 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 Infinity Modular Monitor for display. Such devices include:

Maquet SV 300 ventilator

Maquet Servoi 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, Peotable Blood Gas Analyzer

Baxter Vigilance blood gas/continuous cardiac output monitor

Optical Sensors Inc.: OS -Optical CAM

VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor

Aspect A-2000 BIS Monitor*

Sensormedics Micro Gas 7650

Draeger Fabius Tiro

Draeger Primus

Viasys Bear 1000

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K050974: Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol Converters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050974

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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