JOH · Class II · 21 CFR 868.5800

FDA Product Code JOH: Tube Tracheostomy And Tube Cuff

Leading manufacturers include Bivona Medical Technologies, Mallinckrodt Medical and Covidien.

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
1–24 of 109
Cleared Dec 29, 2025
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula
K251313
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
K210833
Smiths Medical Asd, Inc.
Anesthesiology · 252d
Cleared Aug 05, 2021
TRACOE vario
K203362
Tracoe Medical GmbH
Anesthesiology · 262d
Cleared Jun 01, 2020
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
K193077
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
K193133
Cook Incorporated
Anesthesiology · 30d
Cleared Mar 22, 2019
Shiley Neonatal/Pediatric Tracheostomy Tube
K182861
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
K173912
Smiths Medical Asd, Inc.
Anesthesiology · 137d
Cleared May 07, 2018
Weinmann Tracheostomy Exchange Set
K180034
Cook Incorporated
Anesthesiology · 123d
Cleared Apr 27, 2018
TRACOE silcosoft Tracheostomy Tube
K172720
Tracoe Medical GmbH
Anesthesiology · 231d
Cleared Dec 07, 2017
Portex Blue Line Ultra Paediatric Tracheosomy Tube
K170720
Smiths Medical Asd, Inc.
Anesthesiology · 273d
Cleared Jul 14, 2015
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
K150844
Covidien
Anesthesiology · 106d
Cleared Feb 24, 2015
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula
K142296
Covidien
Anesthesiology · 190d
Cleared Feb 13, 2015
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
K142298
Covidien
Anesthesiology · 179d
Cleared May 23, 2014
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
K133173
Teleflexmedical, Inc.
Anesthesiology · 218d
Cleared Apr 18, 2014
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
K133597
Cook, Inc.
Anesthesiology · 147d
Cleared Sep 06, 2013
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
K122235
Teleflexmedical, Inc.
Anesthesiology · 407d
Cleared Oct 09, 2012
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
K122531
Covidien
Anesthesiology · 50d
Cleared Jan 08, 2010
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K093469
Cook, Inc.
Anesthesiology · 63d
Cleared Feb 23, 2009
BIVONA TRACHEOSTOMY TUBES
K083641
Smiths Medical Asd, Inc.
Anesthesiology · 76d
Cleared Sep 12, 2008
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
K081440
Smiths Medical Asd, Inc.
Anesthesiology · 113d
Cleared Oct 03, 2007
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148
Cook, Inc.
Anesthesiology · 61d
Cleared Jun 16, 2005
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416
Mallinckrodt Medical
Anesthesiology · 15d
Cleared Jul 29, 2004
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044
Cook, Inc.
Anesthesiology · 98d
Cleared Nov 14, 2003
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787
Nellcor Puritan Bennett, Inc.
Anesthesiology · 247d

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 →