# K022889: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 25, 2002 after 26 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). 16 ancestors in all.
289 later devices descend from it; 5 cite it directly.
0 of 306 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.
- K003243: Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K982730: SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K980882: Siemens  SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K013515: Infinity Explorer, Siemens Medical Solutions USA, Inc. (2002)
- K012770: Infinity MICRO2+, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio (2003), 280 descendants of its own
- K041956: Emg - Essential Gas Module, Model M1013A (2004), 251 descendants of its own
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 (2005), 249 descendants of its own
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), 247 descendants of its own
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module (2004), 241 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K022889
Methodology: https://510kreport.com/methodology