510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792035Substantially Equivalent

Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire

Bivona Medical Technologies, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792035 is the FDA 510(k) clearance record for FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE, a class II device, cleared for Bivona Medical Technologies on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 50 510(k) clearances for Bivona Medical Technologies, from to . As of , FDA records show 2 recalls naming K792035.

Clearance record

Decision date
Received
(16 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Bivona Medical Technologies 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BTR

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