# K052977: Datex-Ohmeda S/5 Cardiac Output and SVO2 Module, E-Copsv and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Nov 22, 2005 after 29 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K961063 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961063: AS/3 Cardiac Output & SVO2 Module, Datex Medical Instrumentation, Inc. (1996) Summary page 1.

## Indications for use
The Datex-Ohmeda S/5 TM Cardiac Output and SvO2 module, E-COPSv and accessories is used for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure monitoring of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K052977
Methodology: https://510kreport.com/methodology