# K021200: Compas

- Pathway: 510(k) (Traditional)
- Applicant: Morgan Scientific, Inc.
- Decided: Oct 18, 2002 after 185 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.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190568: ComPAS2 (Computerized Pulmonary Analysis System) (2019), 1 descendant of its own
- K213872: ComPAS2 (2022), 0 descendants of its own

## Indications for use
The ComPAS software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow Test PFT System and the Morgan Transfer Test Benchmark PFT System. ComPAS uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS 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/K021200
Methodology: https://510kreport.com/methodology