# K200832: Safey Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Safey Medical Devices Pvt, Ltd.
- Decided: Jul 30, 2020 after 122 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)
- K181666: Smart One, Mir Medical International Research (2018) Summary page 5.

## Indications for use
Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.

Source page: https://510kreport.com/device/K200832
Methodology: https://510kreport.com/methodology