# K042595: Spiro'air

- Pathway: 510(k) (Traditional)
- Applicant: Morgan Scientific, Inc.
- Decided: May 4, 2005 after 223 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- 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 SpiroAir PFT System is intended to operate with the ComPAS pulmonary function software. ComPAS uses flow and volume readings from the SpiroAir to display the flow and volume information measured directly from patient effort. ComPAS utilizes gas analyzer readings from the SpiroAir to display single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing reports.

Source page: https://510kreport.com/device/K042595
Methodology: https://510kreport.com/methodology