510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935788Substantially Equivalent

Bicore Smartcath Intratracheal Catheter

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

K935788 is the FDA 510(k) clearance record for BICORE SMARTCATH INTRATRACHEAL CATHETER, a class II device, cleared for Bicore Monitoring Systems on under FDA product code MOD (Accessory To Continuous Ventilator (Respirator)). FDA records list 4 510(k) clearances for Bicore Monitoring Systems, from to . As of , FDA records show no recalls naming K935788.

Clearance record

Decision date
Received
(574 days to decision)
Product code
MOD Accessory To Continuous Ventilator (Respirator)
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Bicore Monitoring Systems 2-A Faraday, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOD

Trailing 12 months
3 clearances under product code MOD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260