# K040698: Masterscreen CPX and Oxycon CPX

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: Apr 7, 2004 after 21 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters. The Masterscreen CPX system is intended to use with adults and children over the age of 14 years.

Source page: https://510kreport.com/device/K040698
Methodology: https://510kreport.com/methodology