# K183089: Air Next

- Pathway: 510(k) (Traditional)
- Applicant: Nuvoair AB
- Decided: Jan 2, 2020 after 422 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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 4.

## Most influential descendants
- K222525: Alveoair Digital Spirometer (2023), 0 descendants of its own

## Indications for use
Air Next is intended to be used by: Healthcare professionals trained to perform spirometry tests on patients of age > 5 years old, > 10 kg and > 110 cm. Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.

Source page: https://510kreport.com/device/K183089
Methodology: https://510kreport.com/methodology