# K052976: Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jan 13, 2006 after 81 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 K922876 (1993). 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)
- K922876: AS/3 Cop Module, Datex Division Instrumentarium Corp. (1993) Summary page 1.

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

Source page: https://510kreport.com/device/K052976
Methodology: https://510kreport.com/methodology