510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003315Substantially Equivalent

Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube and Disposable Inner Cannula

Mallinckrodt, Inc., St. Charles MO / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K003315 is the FDA 510(k) clearance record for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA, a class II device, cleared for Mallinckrodt, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list 5 510(k) clearances for Mallinckrodt, Inc., from to . As of , FDA records show one recall naming K003315.

Clearance record

Decision date
Received
(16 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Mallinckrodt, Inc. 3 Missouri Research Park Dr., St. Charles MO
510(k) summary
Summary
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