# K012016: Infinity SC 8000 with Advanced Communication Option II

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 20, 2001 after 22 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K946306 (1995). 5 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983632: Siemens SC 8000 Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K990563: Siemens SC 8000 Bedside Monitor with Advanced Communication Option, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K010640: Siemens Medical Information Bus (Mib II) Protocol Converter, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.

## Most influential descendants
- K042904: Infinity Kappa XLT (2005), 28 descendants of its own
- K060039: Infinity Delta and Kappa Series Monitors with VF6 Modifications (2006), 27 descendants of its own
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL (2007), 26 descendants of its own
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution (2010), 24 descendants of its own
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), 23 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K012016
Methodology: https://510kreport.com/methodology