# K180487: Peak.me

- Pathway: 510(k) (Traditional)
- Applicant: Breathe Me, Ltd.
- Decided: Oct 26, 2018 after 245 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152276: Wing Smart FEVI and Peak Flow Meter, Sparo, Inc. (2016) Summary page 5.

## Indications for use
Peak.me is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.

Source page: https://510kreport.com/device/K180487
Methodology: https://510kreport.com/methodology