# K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 25, 2003 after 211 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: 4 generations back to K946306 (1995). 20 ancestors in all.
280 later devices descend from it; 6 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022889: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer, Siemens Medical Solutions USA, Inc. (2002)
- K012139: Vamos Anesthetic Gas Monitor, Draeger Medical, Inc. (2002)

## Most influential descendants
- 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
- K052801: Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 (2005), 234 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 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.

Source page: https://510kreport.com/device/K031340
Methodology: https://510kreport.com/methodology