# K213872: ComPAS2

- Pathway: 510(k) (Traditional)
- Applicant: Morgan Scientific, Inc.
- Decided: Jul 15, 2022 after 214 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: 2 generations back to K021200 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190568: ComPAS2 (Computerized Pulmonary Analysis System), Morgan Scientific, Inc. (2019) Summary page 4.

## Indications for use
Morgan Scientific's ComPAS2 is a software application intended to be used to connect to compatible Morgan Scientific or third-party devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, occupational health, and research health centers under the supervision of a healthcare provider.

Source page: https://510kreport.com/device/K213872
Methodology: https://510kreport.com/methodology