# K231416: Air Next (NVD-02)

- Pathway: 510(k) (Traditional)
- Applicant: Nuvoair AB
- Decided: Jan 18, 2024 after 247 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: 5 generations back to K943404 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072979: Spirobank G, Mir Medical Intl. Research Srl (2007) Summary page 5.

## Indications for use
NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older. It can be used in hospitals, in the clinical setting, and at home. The Air Next is not intended for use in an operating room. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Source page: https://510kreport.com/device/K231416
Methodology: https://510kreport.com/methodology