510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K253180Substantially Equivalent

Microlife Digital Peak Flow Meter, Model PF200B (PF200B)

Microlife Corp., Taipei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253180 is the FDA 510(k) clearance record for Microlife Digital Peak Flow Meter, Model PF200B (PF200B), a class II device, cleared for Microlife Corporation on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 16 510(k) clearances for Microlife Corporation, from to . As of , FDA records show no recalls naming K253180.

Clearance record

Decision date
Received
(270 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Microlife Corporation 9f, 431, Ruiguang Rd., Neihu, Taipei, TW
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