# K983632: Siemens SC 8000 Bedside Monitor

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 6, 1998 after 22 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: 2 generations back to K946306 (1995). 2 ancestors in all.
293 later devices descend from it; 6 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982730: SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), 247 descendants of its own

## Indications for use
The SC 8000 Bedside monitor is capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Pulse rate (central) apnea ST segment analysis 12-Lead ST Segment Analysis tcp02/CO2 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 Qutput 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 tcpO2/CO2 which is to be used in the neonatal population only. MRI Compatibility Statement: The Siemens SC 8000 Bedside Monitor is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K983632
Methodology: https://510kreport.com/methodology