510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915060Substantially Equivalent

Astech Home Peak Flow Meter

Biotrine Corp., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915060 is the FDA 510(k) clearance record for ASTECH HOME PEAK FLOW METER, a class II device, cleared for Biotrine Corp. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 6 510(k) clearances for Biotrine Corp., from to . As of , FDA records show no recalls naming K915060.

Clearance record

Decision date
Received
(308 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Biotrine Corp. 52 Dragon Ct., Woburn MA
510(k) summary
Statement
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