510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812163Substantially Equivalent

Aire-Cuf Tracheostomy Tube

Bioana Surgical Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812163 is the FDA 510(k) clearance record for AIRE-CUF TRACHEOSTOMY TUBE, a class II device, cleared for Bioana Surgical Instruments, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list one 510(k) clearance for Bioana Surgical Instruments, Inc. As of , FDA records show no recalls naming K812163.

Clearance record

Decision date
Received
(54 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Bioana Surgical Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JOH

Trailing 12 months
1 clearance under product code JOH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260