# K962404: Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 17, 1997 after 210 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 K844187 (1985). 2 ancestors in all.
247 later devices descend from it; 1 cites it directly.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952054: Siemens Sirecust Monitoring (1200, 1200 Neo, 960), Siemens Medical Solutions USA, Inc. (1996) Summary page 1.

## Most influential descendants
- K993974: Siemens Infinity SC 6002XL Portable Patient Monitor (2000), 246 descendants of its own
- K033600: Infinity Gammaxl (2003), 244 descendants of its own
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module (2004), 241 descendants of its own
- K051628: Infinity Monitors with Scio Modifications (2005), 230 descendants of its own
- K053204: Intellivue Gas Modules, Models G5 M1019A and G1 M1013A (2006), 222 descendants of its own

## Indications for use
The intended use statement for the device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia(only for adults), temperature, SpO2 and espgsal apnea. “The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.

Source page: https://510kreport.com/device/K962404
Methodology: https://510kreport.com/methodology