510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081440Substantially Equivalent

Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes

Abbott Medical, Dublin OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081440 is the FDA 510(k) clearance record for BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES, a class II device, cleared for Smiths Medical Asd, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K081440.

Clearance record

Decision date
Received
(113 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Medical Asd, Inc. 6250 Shier Rings Rd., Dublin OH
510(k) summary
Summary PDF
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