# K962291: Siemens SC9000/SC9015 Bedside Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 29, 1997 after 229 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.
3 later devices descend from it; 2 cite it directly.
0 of 6 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 2.

## Most influential descendants
- K970920: Siemens SC9000/SC9015 Bedside Monitoring System (1997), 2 descendants of its own
- K032051: Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P (2004), 1 descendant of its own
- K071164: Life+Cel Battery (2007), 0 descendants of its own

## Indications for use
The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, cardiac output, end-tidal carbon dioxide and (central) apnea. This device will produce visual and aural alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity (Olympus) network.

Source page: https://510kreport.com/device/K962291
Methodology: https://510kreport.com/methodology