# K081776: Continuous Cardiac Ouput Monitor, Truccom

- Pathway: 510(k) (Special)
- Applicant: Omega Critical Care Limited
- Decided: Jul 22, 2008 after 29 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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 K925444 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993245: Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom, Alba Critical Care, Ltd. (1999) Summary page 1.

## Indications for use
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood.

Source page: https://510kreport.com/device/K081776
Methodology: https://510kreport.com/methodology