FDA Product Code JOH: Tube Tracheostomy And Tube Cuff
Leading manufacturers include Smiths Medical Asd, Inc. and Covidien, LLC.
2
Total
2
Cleared
249d
Avg days
2021
Since
List of Tube Tracheostomy And Tube Cuff devices cleared through 510(k)
2 devices
Cleared
Dec 29, 2025
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula
Covidien, LLC
Anesthesiology
245d
Cleared
Nov 26, 2021
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
Smiths Medical Asd, Inc.
Anesthesiology
252d
How to use this database
This page lists all FDA 510(k) submissions for Tube Tracheostomy And Tube Cuff devices (product code JOH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →