510(k) · Cleared
ClearedInfinity Modular Monitors VF4 Modifications
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 Mar 22, 2004 as substantially equivalent to K983632 (Siemens Medical Solutions USA, Inc., 1998) and 5 other predicates after a 119-day review. Its family tree reaches back 5 generations to 1995. 37 later devices descend from it.
- Decided
- Mar 22, 2004
- Review
- 119 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K946306 (1995). 21 ancestors in all, the oldest K900598 (1990). 37 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 4 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- This deviceK033694 Infinity Modular Monitors VF4 ModificationsDraeger 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 |
|---|---|---|---|---|---|
| −5 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −4 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K033694 | Infinity Modular Monitors VF4 Modifications | 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 |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 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 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? (6)
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 |
|---|---|---|---|
| * | K983632 | Siemens SC 8000 Bedside MonitorSummary page 1…Arrhythmia detector & Alarm 74DSI II 21 CFR 870.1025 i&.gally Marketed Device Identification: INFINIiTY SC 8000 Monitor, K983632 / K990563 IiNIiNITY SC 7000 /SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The… | 1998 |
| * | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSummary page 1…rrhythmia detector & Alarm 74DSI II 21 CFR 870.1025 i&.gally Marketed Device Identification: INFINIiTY SC 8000 Monitor, K983632 / K990563 IiNIiNITY SC 7000 /SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The VF4 relea… | 1999 |
| * | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio Cleared while this submission was under review Summary page 1…II 21 CFR 870.1025 i&.gally Marketed Device Identification: INFINIiTY SC 8000 Monitor, K983632 / K990563 IiNIiNITY SC 7000 /SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The VF4 release of the INFINITY Modular monitors supports the "look and f… | 2003 |
| * | K003243 | Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XLSummary page 1…21 CFR 870.1025 i&.gally Marketed Device Identification: INFINIiTY SC 8000 Monitor, K983632 / K990563 IiNIiNITY SC 7000 /SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The VF4 release of the INFINITY Modular monitors supports the "look and feel" of t… | 2000 |
| * | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1…870.1025 i&.gally Marketed Device Identification: INFINIiTY SC 8000 Monitor, K983632 / K990563 IiNIiNITY SC 7000 /SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The VF4 release of the INFINITY Modular monitors supports the "look and feel" of the Draeg… | 1998 |
| * | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1…i&.gally Marketed Device Identification: INFINIiTY SC 8000 Monitor, K983632 / K990563 IiNIiNITY SC 7000 /SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The VF4 release of the INFINITY Modular monitors supports the "look and feel" of the Draeger Medica… | 1998 |
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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K043439 (Draeger Medical Systems, Inc., 2005) has gone furthest, with 36 descendants of its own.
- 5 other devices also cite its predicate K983632.
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 The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of…
Read the full statement (268 words)
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
The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033694: Infinity Modular Monitors VF4 Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033694
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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