# K193311: Aluna

- Pathway: 510(k) (Traditional)
- Applicant: Knox Medical Diagnostics, Inc.
- Decided: Mar 25, 2020 after 117 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: 5 generations back to K943678 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181666: Smart One, Mir Medical International Research (2018) Summary page 4.
- K152276: Wing Smart FEVI and Peak Flow Meter, Sparo, Inc. (2016) Summary page 4.

## Most influential descendants
- K232588: Aluna 2 (2024), 0 descendants of its own

## Indications for use
Aluna 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 children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.

Source page: https://510kreport.com/device/K193311
Methodology: https://510kreport.com/methodology