510(k) · Cleared
ClearedSiemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer
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 Sep 25, 2002 as substantially equivalent to K983632 (Siemens Medical Solutions USA, Inc., 1998) and 6 other predicates after a 26-day review. Its family tree reaches back 3 generations to 1995. 289 later devices descend from it.
- Decided
- Sep 25, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K946306 (1995). 16 ancestors in all, the oldest K900598 (1990). 289 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 2 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 1 generation backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- This deviceK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- Descendant · 2 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
- Descendant · 3 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 4 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 2 generations on · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
Showing 5 of 289 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 289 · See all- K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · cites it directly280descendants
- K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 2 generations on251descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on247descendants
- K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · 2 generations on241descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −2 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −1 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +2 | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +3 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +4 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +2 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 14 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 11 | 0 |
| 2012 | 11 | 0 |
| 2013 | 13 | 0 |
| 2014 | 11 | 0 |
| 2015 | 11 | 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? (7)
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…nitor, Physiological, Patient (with MHX I11 2 1 CFR 870.1025 Legally Marketed Device Identification: INFINITY SC 8000 Monitor, 5 10(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 51O(k) K003243/K982730/ K980882 INFINITYExplorer, 5 1O(k) KO 13515… | 1998 |
| * | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSummary page 1…siological, Patient (with MHX I11 2 1 CFR 870.1025 Legally Marketed Device Identification: INFINITY SC 8000 Monitor, 5 10(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 51O(k) K003243/K982730/ K980882 INFINITYExplorer, 5 1O(k) KO 13515 MICR02… | 1999 |
| * | K003243 | Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XLSummary page 1…CFR 870.1025 Legally Marketed Device Identification: INFINITY SC 8000 Monitor, 5 10(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 51O(k) K003243/K982730/ K980882 INFINITYExplorer, 5 1O(k) KO 13515 MICR02+, 5 10(k) KO12770 Description of Modification: The mo… | 2000 |
| * | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1….1025 Legally Marketed Device Identification: INFINITY SC 8000 Monitor, 5 10(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 51O(k) K003243/K982730/ K980882 INFINITYExplorer, 5 1O(k) KO 13515 MICR02+, 5 10(k) KO12770 Description of Modification: The modificati… | 1998 |
| * | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1…Legally Marketed Device Identification: INFINITY SC 8000 Monitor, 5 10(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 51O(k) K003243/K982730/ K980882 INFINITYExplorer, 5 1O(k) KO 13515 MICR02+, 5 10(k) KO12770 Description of Modification: The modifications imple… | 1998 |
| * | K013515 | Infinity Explorer | 2002 |
| * | K012770 | Infinity MICRO2+Summary page 1…following primary modifications: 1. Wireless capability 2. Non-invasive blood pressure with step deflation 3. MICR02+ (K012770) interface 4. Support for Masimo sensors 1of3 Siemens… | 2002 |
| † | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | 1996 |
What descends from it? (289)
See all 2895 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 7 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K031340 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 280 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 tcp02/tcpC02 EEG signals Fl02 With the MultiCas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen…
Read the full statement (257 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
tcp02/tcpC02
EEG signals
Fl02
With the MultiCas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.
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; etCO2 sidestream which is not available in neonatal mode; 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/K022889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022889: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022889
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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