# K080510: Vip Pulmonary Function System

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: Aug 20, 2008 after 177 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- 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 VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below. · Differential diagnosis (heart/lungs) · Disability assessment *Rehabilitation evaluation · Exercise prescription * Sports medicine/research * Energy assessment, substrate utilization *Assessment of supplemental 02 requirement * Evaluation of medication effects · Pulmonary Function testing for adults and children · Document effectiveness of bronchodilator therapy *Pulmonary disability evaluation *Industrial surveillance *Bronchial challenge testing * Exercise induced bronchial spasm · Pie-surgical risk evaluation · Bedside lung function

Source page: https://510kreport.com/device/K080510
Methodology: https://510kreport.com/methodology