510(k) · Cleared
ClearedInfinity SC 8000 with Advanced Communication Option II
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 Jul 20, 2001 as substantially equivalent to K983632 (Siemens Medical Solutions USA, Inc., 1998) and 2 other predicates after a 22-day review. Its family tree reaches back 3 generations to 1995. 29 later devices descend from it.
- Decided
- Jul 20, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K946306 (1995). 5 ancestors in all. 29 later devices descend from it, 1 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 deviceK012016 Infinity SC 8000 with Advanced Communication Option IISiemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 28 of its ownK042904 Infinity Kappa XLTDraeger 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 · 3 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 · 4 generations on · 24 of its ownK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · Recalled
- Descendant · 5 generations on · 23 of its ownK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K042904Infinity Kappa XLTDraeger Medical Systems, Inc. · 2005 · cites it directly28descendants
- 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 · 3 generations on26descendants
- K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · 4 generations on24descendants
- K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · 5 generations on23descendants
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) | K012016 | Infinity SC 8000 with Advanced Communication Option II | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +1 | K042904 | Infinity Kappa XLT | Draeger Medical Systems, Inc. | 2005 | — |
| +2 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +3 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| +4 | K093788 | Infinity Acute Care System (Iacs) Monitoring Solution | Draeger Medical Systems, Inc. | 2010 | 4 |
| +5 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 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? (3)
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…th MHX I 21 CFR 870.1025 arrhythmia detection or alarms) {_Arthythmia detector & Alarm 74DSI I 21 CFR 870.1025 Legally Marketed Device Identification: Siemens SC 8000 K983632 SC 8000 w/Advanced Communication Option, K990563 Siemens INFINITY MIB Il Protocol Converter, K010640 Description of Madificatio… | 1998 |
| * | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSummary page 1…alarms) {_Arthythmia detector & Alarm 74DSI I 21 CFR 870.1025 Legally Marketed Device Identification: Siemens SC 8000 K983632 SC 8000 w/Advanced Communication Option, K990563 Siemens INFINITY MIB Il Protocol Converter, K010640 Description of Madification: The SC 8000 Advanced Communication Option II is… | 1999 |
| * | K010640 | Siemens Medical Information Bus (Mib II) Protocol ConverterSummary page 1…R 870.1025 Legally Marketed Device Identification: Siemens SC 8000 K983632 SC 8000 w/Advanced Communication Option, K990563 Siemens INFINITY MIB Il Protocol Converter, K010640 Description of Madification: The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it… | 2001 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042904 | Infinity Kappa XLT | 2005 | 28 |
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 6 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K042904 (Draeger Medical Systems, Inc., 2005) has gone furthest, with 28 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 SC 8000 Monitor is capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia “Iemperature Cardiac output Arterial oxygen saturation Pulse rate Apnea ST Segment Analysis 12-Lead ST Segment Analysis cpO2/tcpCO2 EEG signals FiO2 e & @ ¢ ® 6 & 5 2 0 s 0 ¢ 0 0 With the MultiGas and MultiGas+ modules the monitor is capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired…
Read the full statement (280 words)
The INFINITY SC 8000 Monitor is capable of monitoring:
Heart rate
Respiration rate
Invasive pressure
Non-invasive pressure
Arrhythmia
“Iemperature
Cardiac output
Arterial oxygen saturation
Pulse rate
Apnea
ST Segment Analysis
12-Lead ST Segment Analysis
cpO2/tcpCO2
EEG signals
FiO2
e & @ ¢ ® 6 & 5 2 0 s 0 ¢ 0 0
With the MultiGas and MultiGas+ modules the monitor is 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 monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode
With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.
The monitor can interface with specific third party devices via an MIB protocol converter.
The device is 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 device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the aduil and pediairic populations only; Arrkythmia which is not intended for use 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 SC 8000 Monitor is not compatible for use in a MRI magnetic field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012016: Infinity SC 8000 with Advanced Communication Option II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012016
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026