# K201493: Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Mehow Innovative, Ltd.
- Decided: Jun 10, 2021 after 371 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090646: Cardiotech Spirometry System, Model GT-105, Chest M.I., Inc. (2009) Summary page 5.

## Indications for use
The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient’s lungs. The system is intended for use with pediatric (5 to 21 years) and adult (22 years and older) patients in hospitals, physician’s offices, laboratories, and occupational health environments.

Source page: https://510kreport.com/device/K201493
Methodology: https://510kreport.com/methodology