# K230423: Electronic Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Taian Dalu Medical Instrument Co., Ltd.
- Decided: Feb 23, 2024 after 371 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.
No later device cites it as a predicate yet.
0 of 3 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 5.

## Indications for use
This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.

Source page: https://510kreport.com/device/K230423
Methodology: https://510kreport.com/methodology