# K222443: Air Smart Extra Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Feellife Health, Inc.
- Decided: Aug 9, 2023 after 362 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The spirometer (Air Smart Extra) 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/K222443
Methodology: https://510kreport.com/methodology