# K152276: Wing Smart FEVI and Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Sparo, Inc.
- Decided: Jun 3, 2016 after 296 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: 4 generations back to K943678 (1995). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software), Microlife Intellectual Property GmbH (2004) Summary page 5.

## Most influential descendants
- K193311: Aluna (2020), 1 descendant of its own
- K232588: Aluna 2 (2024), 0 descendants of its own
- K201635: MouthLab Vital Signs Monitoring System (2021), 0 descendants of its own
- K180487: Peak.me (2018), 0 descendants of its own

## Indications for use
Wing 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. Wing is not recommended for children under 5 years of age.

Source page: https://510kreport.com/device/K152276
Methodology: https://510kreport.com/methodology