Peak Flow Meter (PF-10(BR-PEF231))— 510(k) K252802

Name: FDA 510(k) clearance K252802
Creator: U.S. Food and Drug Administration
Published: 2026-05-29

Substantially Equivalent

Shenzhen Bi-Rich Medical Devices Co., Ltd.

FDA 510(k) clearance K252802 for Peak Flow Meter (PF-10(BR-PEF231)), Substantially Equivalent on 2026-05-29. Applicant: Shenzhen Bi-Rich Medical Devices Co., Ltd.. Device class: 2.

Summary

Shenzhen Bi-Rich Medical Devices filed the Peak Flow Meter (PF-10(BR-PEF231)) under BZH, peak flow spirometry meters. Apart from the model number, the name is generic.

Class II, 21 CFR 868.1860. Anesthesiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).

The company is in Shenzhen, China. FDA received the file on September 3, 2025 and decided it on May 29, 2026, 268 calendar days later.

Clearance details

Applicant: Shenzhen Bi-Rich Medical Devices Co., Ltd.
Product code: Product code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2025-09-03
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZH

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K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B)2026-06-23
K241338 — Peak Flow Meter2024-12-31
K232588 — Aluna 22024-11-25
K230423 — Electronic Peak Flow Meter2024-02-23
K222810 — TD-7301 Peak Flow meter2023-12-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.