510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896718Substantially Equivalent

Bicore Variflex(r) Flow Transducer

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

K896718 is the FDA 510(k) clearance record for BICORE VARIFLEX(R) FLOW TRANSDUCER, a class I device, cleared for Bicore Monitoring Systems on under FDA product code BYR (Transducer, Gas Pressure, Differential). FDA records list 4 510(k) clearances for Bicore Monitoring Systems, from to . As of , FDA records show no recalls naming K896718.

Clearance record

Decision date
Received
(85 days to decision)
Product code
BYR Transducer, Gas Pressure, Differential
Regulation
21 CFR 868.2875
Device class
Class I
Review panel
Anesthesiology
Applicant
Bicore Monitoring Systems 2 Faraday, Irvine CA
Third party review
No

Clearances, product code BYR

Trailing 12 months

FDA records hold no clearances under product code BYR in the trailing twelve months.

FDA records show no clearances under product code BYR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYR, 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 20260
October 20260