FDA Product Code BTO: Tube, Tracheostomy (w/wo Connector)
Leading manufacturers include Shiley, Inc., Bivona Medical Technologies and Hood Laboratories.
128
Total
128
Cleared
107d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
259d
recently vs 106d historically
FDA 510(k) Cleared Tube, Tracheostomy (w/wo Connector) Devices (Product Code BTO)
128 devices
Cleared
Jun 10, 2025
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm
Vitaltec Corporation
Anesthesiology
259d
Cleared
Mar 22, 2024
Pilling Tracheostomy Tubes
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
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
Smiths Medical Ads, Inc.
Anesthesiology
162d
Cleared
May 24, 2012
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
Primed Halberstadt Medizintechnik GmbH
Anesthesiology
135d
Cleared
Apr 23, 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
Cook, Inc.
Anesthesiology
81d
Cleared
Aug 18, 2009
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
Smiths Medical Asd, Inc.
Anesthesiology
312d
Cleared
Oct 25, 2005
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
Tracoe Medical GmbH
Anesthesiology
132d
Cleared
Jul 12, 2005
CS MEDICAL ADULT TTCF CATHETER
Cs Medical, Inc.
Anesthesiology
147d
Cleared
Feb 17, 2005
WELL LEAD TRACHEOSTOMY TUBE
Well Lead Medical Instruments
Anesthesiology
141d
Cleared
Jul 23, 2002
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
Rusch Intl.
Anesthesiology
55d
Cleared
Oct 27, 1999
CRICOTHYROTOMY TUBE
Polamedco, Inc.
Anesthesiology
426d
Cleared
Jun 17, 1998
SCOOP 1
Transtracheal Systems
Anesthesiology
85d
Cleared
Mar 19, 1997
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
VBM Medizintechnik GmbH
Anesthesiology
476d
Cleared
Aug 27, 1996
CPR TRACHEOTOMY CARE TRAY
Custom Pack Reliability
Anesthesiology
224d
Cleared
Aug 15, 1996
MOORE TRACHEOSTOMY TUBE
Boston Medical Products, Inc.
Anesthesiology
65d
Cleared
May 16, 1996
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
Seidel Medizin GmbH
Anesthesiology
331d
Cleared
Sep 02, 1992
LOW PROFILE TRACHEOSTOMY TUBE
Concord/Portex
Anesthesiology
86d
Cleared
Aug 27, 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
Trinity Laboratories, Inc.
Anesthesiology
218d
Cleared
Aug 27, 1992
TRACHEOSTOMY CARE KIT
Trinity Laboratories, Inc.
Anesthesiology
163d
Cleared
Jul 27, 1992
BIVONA TRACHEAL T-TUBE STENT
Bivona Medical Technologies
Anesthesiology
167d
Cleared
Aug 16, 1991
TRACHEOSTOMY TUBE AND CUFF
Concord/Portex
Anesthesiology
95d
Cleared
Jun 19, 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
Bivona Medical Technologies
Anesthesiology
15d
Cleared
Sep 25, 1990
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
Concord/Portex
Anesthesiology
40d
About Product Code BTO - Regulatory Context
510(k) Submission Activity
128 total 510(k) submissions under product code BTO since 1976, with 128 receiving FDA clearance (average review time: 107 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - BTO Product Code
Recent submissions under BTO have taken an average of 259 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 →