# K970920: Siemens SC9000/SC9015 Bedside Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 29, 1997 after 139 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: 3 generations back to K844187 (1985). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 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 2.
- K954632: Siemens SC 9000 ETCO2 Module, Siemens Medical Solutions USA, Inc. (1996) Summary page 2.
- K962291: Siemens SC9000/SC9015 Bedside Monitoring System, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K951371: 1481 T Digital Telemetry System with S-T Segment Analysis Option, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.

## Most influential descendants
- 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
This device is capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult only), temperature, cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide and (central) apnea and ST Segment Analysis (adult only). This device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.

Source page: https://510kreport.com/device/K970920
Methodology: https://510kreport.com/methodology