510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921717Substantially Equivalent

Bicore Smartvalve Occlusion Valve

Bicore Monitoring Systems, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921717 is the FDA 510(k) clearance record for BICORE SMARTVALVE OCCLUSION VALVE, a class II device, cleared for Bicore Monitoring Systems on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list 4 510(k) clearances for Bicore Monitoring Systems, from to . As of , FDA records show no recalls naming K921717.

Clearance record

Decision date
Received
(211 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Bicore Monitoring Systems 2 Faraday, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code BZK

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