510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252802Substantially Equivalent

Peak Flow Meter (PF-10(BR-PEF231))

Shenzhen BI-Rich Medical Devices Co., Ltd, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252802 is the FDA 510(k) clearance record for Peak Flow Meter (PF-10(BR-PEF231)), a class II device, cleared for Shenzhen Bi-Rich Medical Devices Co., Ltd. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list one 510(k) clearance for Shenzhen Bi-Rich Medical Devices Co., Ltd. As of , FDA records show no recalls naming K252802.

Clearance record

Decision date
Received
(268 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Shenzhen Bi-Rich Medical Devices Co., Ltd. The 1st Bldg. Of # 10, Xinqiao Gangzai Rd., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZH

Trailing 12 months
2 clearances under product code BZH in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260