510(k) · Cleared
ClearedSiemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 25, 2003 as substantially equivalent to K022889 (Siemens Medical Solutions USA, Inc., 2002) and 1 other predicate after a 211-day review. Its family tree reaches back 4 generations to 1995. 280 later devices descend from it.
- Decided
- Nov 25, 2003
- Review
- 211 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K946306 (1995). 20 ancestors in all, the oldest K900598 (1990). 280 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 3 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 1 generation backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- This deviceK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
- Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 3 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · cites it directly · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 280 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 280 · See all- K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · cites it directly251descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on247descendants
- K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · cites it directly241descendants
- K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on234descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −3 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −1 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +2 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +3 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +1 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| +3 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
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 |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 13 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 11 | 0 |
| 2015 | 10 | 0 |
| 2016 | 13 | 0 |
| 2017 | 13 | 0 |
| 2018 | 15 | 0 |
| 2019 | 11 | 0 |
| 2020 | 11 | 0 |
| 2021 | 14 | 0 |
| 2022 | 20 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens… | 2002 |
| * | K012139 | Vamos Anesthetic Gas Monitor | 2002 |
| † | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | 1997 |
| † | K012016 | Infinity SC 8000 with Advanced Communication Option II | 2001 |
| † | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | 1998 |
| † | K003243 | Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL | 2000 |
| † | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication Option | 1999 |
| † | K983632 | Siemens SC 8000 Bedside Monitor | 1998 |
What descends from it? (280)
See all 2806 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041956 | Emg - Essential Gas Module, Model M1013A | 2004 | 251 |
| K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | 2004 | 241 |
| K033957 | Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC… | 2004 | 233 |
| K051628 | Infinity Monitors with Scio Modifications | 2005 | 230 |
| K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | 2006 | 222 |
| K033694 | Infinity Modular Monitors VF4 Modifications | 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 8 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K041956 (Draeget Medical AG & Co. Kgaa, 2004) has gone furthest, with 251 descendants of its own.
- 4 other devices also cite its predicate K022889.
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 Fi02 The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of C02, N2O, O2 and one of the…
Read the full statement (255 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
Fi02
The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of C02, 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 etC02 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etC02+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via a 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 patients, with the exception of the parameter Cardiac Output, ST Segment Analysis, etC02 sidestream, 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/K031340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031340
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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