510(k) · Cleared
ClearedInfinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 18, 2005 as substantially equivalent to K033694 (Draeger Medical Systems, Inc., 2004) and 1 other predicate after a 66-day review. Its family tree reaches back 7 generations to 1992. 36 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K923682 (1992). 33 ancestors in all, the oldest K900598 (1990). 36 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 6 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 5 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 4 generations backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- 3 generations backK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- This deviceK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- Descendant · cites it directly · 32 of its ownK051658 Infinity AlphaDraeger Medical Systems, Inc. · 2005
- Descendant · cites it directly · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · cites it directly · 26 of its ownK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 26 of its ownK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
- Descendant · 3 generations on · 25 of its ownK130711 Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K051658Infinity AlphaDraeger Medical Systems, Inc. · 2005 · cites it directly32descendants
- 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 · cites it directly26descendants
- K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007 · 2 generations on26descendants
- K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −6 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −5 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −4 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −3 | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista… | Draeger Medical Systems, Inc. | 2005 | — |
| +1 | K051658 | Infinity Alpha | Draeger Medical Systems, Inc. | 2005 | — |
| +1 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +1 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| +2 | K061379 | Infinity Telesmart Telemetry System | Draeger Medical Systems, Inc. | 2007 | — |
| +3 | K130711 | Infinity Centralstation with Infinity M300 | Draeger Medical Systems, Inc. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K033694 | Infinity Modular Monitors VF4 ModificationsSummary page 1…nication, MSX II 8'0.2300 Physiological Monitors Legally Marketed Device: Infinity Modular Monitors K033694 Infinity MIB K033807 Description of Device Modifications: Software version VF… | 2004 |
| * | K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterSummary page 1…ogical Monitors Legally Marketed Device: Infinity Modular Monitors K033694 Infinity MIB K033807 Description of Device Modifications: Software version VF5 is the latest release of the Infinity Modular Monitors, including… | 2004 |
What descends from it? (36)
See all 363 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 13 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 33 ancestors has a recall.
- Of its descendants, K051658 (Draeger Medical Systems, Inc., 2005) has gone furthest, with 32 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The INFINITY Modular monitors are capable of monitoring:
* Heart rate
* Respiration rate
* Invasive pressure
* Non-invasive pressure
* Arrhythmia
* Temperature
* Cardiac output
* Arterial oxygen saturation
* Pulse rate
* Apnea
* ST Segment Analysis
* 12-Lead ST Segment Analysis
* tcpO2/tcpCO2
* EEG signals
* FiO2
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043439 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043439
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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