# K150137: SpiroThor

- Pathway: 510(k) (Traditional)
- Applicant: Cohero Health, LLC
- Decided: May 27, 2015 after 125 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: 3 generations back to K944762 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092813: Astrasonic Spirometer, Model 29-8000, Sdi Diagnostics, Inc. (2010) Summary page 4.

## Indications for use
SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians’ offices, industrial medical, and hospital settings.

Source page: https://510kreport.com/device/K150137
Methodology: https://510kreport.com/methodology