# K191239: Smart Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Homesun Medical Technology Co., Ltd.
- Decided: Dec 6, 2019 after 212 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: 2 generations back to K133975 (2014). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170281: MSA100BT Peak Flow Meter, Beijing M&B Electronic Instruments Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K203196: Peak flow meter (2021), 0 descendants of its own

## Indications for use
This device is intended to monitor a patient’s Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.

Source page: https://510kreport.com/device/K191239
Methodology: https://510kreport.com/methodology