FDA Product Code JOH: Tube Tracheostomy And Tube Cuff
Leading manufacturers include Tracoe Medical GmbH, Smiths Medical Asd, Inc. and Cook Incorporated.
109
Total
109
Cleared
152d
Avg days
1976
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
245d
recently vs 151d historically
FDA 510(k) Cleared Tube Tracheostomy And Tube Cuff Devices (Product Code JOH)
109 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
Cleared
Aug 05, 2021
TRACOE vario
Tracoe Medical GmbH
Anesthesiology
262d
Cleared
Jun 01, 2020
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
Covidien
Anesthesiology
209d
Cleared
Dec 12, 2019
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
Cook Incorporated
Anesthesiology
30d
Cleared
Mar 22, 2019
Shiley Neonatal/Pediatric Tracheostomy Tube
Covidien
Anesthesiology
162d
Cleared
May 08, 2018
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
Smiths Medical Asd, Inc.
Anesthesiology
137d
Cleared
May 07, 2018
Weinmann Tracheostomy Exchange Set
Cook Incorporated
Anesthesiology
123d
Cleared
Apr 27, 2018
TRACOE silcosoft Tracheostomy Tube
Tracoe Medical GmbH
Anesthesiology
231d
About Product Code JOH - Regulatory Context
510(k) Submission Activity
109 total 510(k) submissions under product code JOH since 1976, with 109 receiving FDA clearance (average review time: 152 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - JOH Product Code
Recent submissions under JOH have taken an average of 245 days to reach a decision - up from 151 days historically. Manufacturers should account for longer review timelines in current project planning.
JOH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →