# K232588: Aluna 2

- Pathway: 510(k) (Traditional)
- Applicant: Knox Medical Diagnostics
- Decided: Nov 25, 2024 after 458 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- 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 K943678 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193311: Aluna, Knox Medical Diagnostics, Inc. (2020) Summary page 5.

## Indications for use
Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

Source page: https://510kreport.com/device/K232588
Methodology: https://510kreport.com/methodology