# K253180: Microlife Digital Peak Flow Meter, Model PF200B (PF200B)

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Corporation
- Decided: Jun 23, 2026 after 270 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
The Microlife Digital Peak Flow Meter (Model PF200B) is intended for monitoring Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) for patient home use. The device is designed for pediatric (≥5 years of age) to adult patients.

Source page: https://510kreport.com/device/K253180
Methodology: https://510kreport.com/methodology