# K190568: ComPAS2 (Computerized Pulmonary Analysis System)

- Pathway: 510(k) (Special)
- Applicant: Morgan Scientific, Inc.
- Decided: Jun 6, 2019 after 92 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
Longest line of descent: 1 generation back to K021200 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021200: Compas, Morgan Scientific, Inc. (2002) Summary page 4.

## Most influential descendants
- K213872: ComPAS2 (2022), 0 descendants of its own

## Indications for use
The ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test PFT system and the Morgan transfer test benchmark PFT system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transflow test and transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing and reports.

Source page: https://510kreport.com/device/K190568
Methodology: https://510kreport.com/methodology