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 Cook, Inc..

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
1–24 of 128
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 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 Jul 23, 2002
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764
Rusch Intl.
Anesthesiology · 55d
Cleared Aug 27, 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281
Trinity Laboratories, Inc.
Anesthesiology · 218d
Cleared Aug 27, 1992
TRACHEOSTOMY CARE KIT
K921281
Trinity Laboratories, Inc.
Anesthesiology · 163d
Cleared Jul 27, 1992
BIVONA TRACHEAL T-TUBE STENT
K920604
Bivona Medical Technologies
Anesthesiology · 167d
Cleared Jun 19, 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469
Bivona Medical Technologies
Anesthesiology · 15d
Cleared Apr 23, 1990
SHILEY PHONATION VALVE
K900548
Shiley, Inc.
Anesthesiology · 77d
Cleared Jan 17, 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730
Shiley, Inc.
Anesthesiology · 68d
Cleared Nov 02, 1988
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
K884427
Bivona Medical Technologies
Anesthesiology · 13d
Cleared Mar 09, 1988
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614
Shiley, Inc.
Anesthesiology · 22d
Cleared Feb 12, 1988
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247
Shiley, Inc.
Anesthesiology · 23d
Cleared May 14, 1987
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181
Cook, Inc.
Anesthesiology · 119d
Cleared Jan 15, 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061
Shiley, Inc.
Anesthesiology · 22d
Cleared Jun 18, 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267
Bivona Medical Technologies
Anesthesiology · 5d
Cleared Jan 27, 1986
LARYNGECTOMY TUBE, CUFFED
K860176
Sheridan Catheter Corp.
Anesthesiology · 10d
Cleared Sep 05, 1985
LGT TUBE
K852413
Mallinckrodt Critical Care
Anesthesiology · 91d
Cleared Jul 08, 1985
BIVONA TRACHEOSTOMA VALVE II
K852272
Bivona Medical Technologies
Anesthesiology · 41d
Cleared Oct 19, 1984
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729
Shiley, Inc.
Anesthesiology · 25d
Cleared Oct 19, 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730
Shiley, Inc.
Anesthesiology · 25d

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 →