# K982730: SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 24, 1998 after 39 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 1 generation back to K946306 (1995). 1 ancestor in all.
298 later devices descend from it; 7 cite it directly.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K983632: Siemens SC 8000 Bedside Monitor (1998), 293 descendants of its own
- K022889: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer (2002), 289 descendants of its own
- 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

## Indications for use
The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Pulse rate End-tidal carbon dioxide (central) apnea ST Segment Analysis 12-Lead ST Segment Analysis Transcutaneous Oxygen and Transcutaneous Carbon Dioxide (tpO2/CO2) With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL 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. The SC 7000 and SC 9000XL can interface with third party devices. 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 and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and Transcutaneous Oxygen which is intended for use in the neonatal population when the patient is not under gas anesthesia. MRI Compatibility Statement: The Siemens SC 7000 and SC 9000XL INFINITY Modular Bedside Monitors are not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K982730
Methodology: https://510kreport.com/methodology