# K203196: Peak flow meter

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Sonmol Medical Equipment Co., Ltd.
- Decided: May 26, 2021 after 210 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: 3 generations back to K133975 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191239: Smart Peak Flow Meter, Guangzhou Homesun Medical Technology Co., Ltd. (2019) Summary page 4.

## 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. The device is for Over-The-Counter Use.

Source page: https://510kreport.com/device/K203196
Methodology: https://510kreport.com/methodology