# K222525: Alveoair Digital Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Roundworks Technologies Private Limited
- Decided: Aug 28, 2023 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: 6 generations back to K943404 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183089: Air Next, Nuvoair AB (2020) Summary page 4.

## Indications for use
The alveoair Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged ≥ 22 years by healthcare professionals or clinicians in any healthcare environment. The use of an alveoair Digital Spirometer is not intended for use during patient transport.

Source page: https://510kreport.com/device/K222525
Methodology: https://510kreport.com/methodology