BTO · Class II · 21 CFR 868.5800

FDA Product Code BTO: Tube, Tracheostomy (w/wo Connector)

Leading manufacturers include Shiley, Inc., Bivona Medical Technologies and American Healthcare Corp..

129
Total
129
Cleared
109d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 307d recently vs 106d historically

FDA 510(k) Cleared Tube, Tracheostomy (w/wo Connector) Devices (Product Code BTO)

129 devices
1–24 of 129
Cleared Sep 11, 2026
Venti-Trach Tracheostomy Tube (570 Series)
K253063
Vitaltec Corporation
Anesthesiology · 354d
Cleared Jun 10, 2025
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm
K242921
Vitaltec Corporation
Anesthesiology · 259d
Cleared Mar 22, 2024
Pilling Tracheostomy Tubes
K233713
Teleflex Medical
Anesthesiology · 123d
Cleared Jul 22, 2020
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
K192511
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 314d
Cleared Apr 10, 2018
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384
Smiths Medical Ads, Inc.
Anesthesiology · 162d
Cleared May 24, 2012
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
K120079
Primed Halberstadt Medizintechnik GmbH
Anesthesiology · 135d
Cleared Mar 24, 2011
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K101721
Regulatory and Marketing Services, Inc.
Anesthesiology · 279d
Cleared Jul 13, 2010
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
K100950
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 98d
Cleared Jun 11, 2010
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
K100480
Vitaltec Corporation
Anesthesiology · 113d
Cleared Apr 23, 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283
Cook, Inc.
Anesthesiology · 81d
Cleared Aug 18, 2009
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031
Smiths Medical Asd, Inc.
Anesthesiology · 312d
Cleared Jun 26, 2008
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
K073702
Lazarus Medical, LLC
Anesthesiology · 178d
Cleared Apr 20, 2007
TALKING TRACH
K062104
Engineered Medical Systems, Inc.
Anesthesiology · 270d
Cleared Jun 19, 2006
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K060945
Smiths Medical International
Anesthesiology · 74d
Cleared Oct 25, 2005
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
K051587
Tracoe Medical GmbH
Anesthesiology · 132d
Cleared Jul 12, 2005
CS MEDICAL ADULT TTCF CATHETER
K050379
Cs Medical, Inc.
Anesthesiology · 147d
Cleared Feb 17, 2005
WELL LEAD TRACHEOSTOMY TUBE
K042684
Well Lead Medical Instruments
Anesthesiology · 141d
Cleared Nov 18, 2003
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
K031553
Arcadia Medical Corporation
Anesthesiology · 183d
Cleared Sep 17, 2003
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
K030570
Portex , Ltd.
Anesthesiology · 205d
Cleared Aug 27, 2003
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
K030381
Portex , Ltd.
Anesthesiology · 203d
Cleared Jul 23, 2002
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764
Rusch Intl.
Anesthesiology · 55d
Cleared Oct 27, 1999
CRICOTHYROTOMY TUBE
K983000
Polamedco, Inc.
Anesthesiology · 426d
Cleared Jun 17, 1998
SCOOP 1
K981080
Transtracheal Systems
Anesthesiology · 85d
Cleared Mar 19, 1997
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
K955461
VBM Medizintechnik GmbH
Anesthesiology · 476d

About Product Code BTO - Regulatory Context

510(k) Submission Activity

129 total 510(k) submissions under product code BTO since 1976, with 129 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BTO Product Code

Recent submissions under BTO have taken an average of 307 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.

BTO devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →