ClearanceBrief
Panels › Anesthesiology › Product code BTO · Class 2

Tube, Tracheostomy (W/Wo Connector)

Regulation 868.5800

1510(k)s in 12 months (129 all time)
1recalls in 12 months (73 all time)
69recalls that name a 510(k)
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Top companies in BTO

Company510(k)sRecalls
Smiths Medical Asd, Inc.155
Shiley, Inc.130
Bivona Medical Technologies60
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)06
American Healthcare Corp.50
Frederic J. Toye, M.D.50
Hood Laboratories40
Portex , Ltd.31
Arcadia Medical Corporation12
Boston Medical Products, Inc.30
Decided510(k)Device and applicantCode
Sep 11, 2026K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (5
Vitaltec Corporation, TW
BTO
Jun 10, 2025K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach D
Vitaltec Corporation, TW
BTO
Mar 22, 2024K233713Pilling Tracheostomy Tubes
Teleflex Medical
BTO
Jul 22, 2020K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (T
Venner Medical (Singapore) Pte, Ltd., SG
BTO
Apr 10, 2018K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dila
Smiths Medical Ads, Inc.
BTO
May 24, 2012K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
Primed Halberstadt Medizintechnik GmbH, DE
BTO
Mar 24, 2011K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Regulatory and Marketing Services, Inc.
BTO
Jul 13, 2010K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
Venner Medical (Singapore) Pte, Ltd.
BTO
Jun 11, 2010K100480ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
Vitaltec Corporation, TW
BTO
Apr 23, 2010K100283VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
Cook, Inc.
BTO
Aug 18, 2009K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
Smiths Medical Asd, Inc., GB
BTO
Jun 26, 2008K073702PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
Lazarus Medical, LLC
BTO
Apr 20, 2007K062104TALKING TRACH
Engineered Medical Systems, Inc.
BTO
Jun 19, 2006K060945PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
Smiths Medical International, GB
BTO
Oct 25, 2005K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
Tracoe Medical GmbH
BTO
Jul 12, 2005K050379CS MEDICAL ADULT TTCF CATHETER
Cs Medical, Inc.
BTO
Feb 17, 2005K042684WELL LEAD TRACHEOSTOMY TUBE
Well Lead Medical Instruments
BTO
Nov 18, 2003K031553SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
Arcadia Medical Corporation
BTO
Sep 17, 2003K030570BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
Portex , Ltd., GB
BTO
Aug 27, 2003K030381PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
Portex , Ltd., GB
BTO
Jul 23, 2002K021764RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
Rusch Intl.
BTO
Oct 27, 1999K983000CRICOTHYROTOMY TUBE
Polamedco, Inc.
BTO
Jun 17, 1998K981080SCOOP 1
Transtracheal Systems
BTO
Mar 19, 1997K955461TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
VBM Medizintechnik GmbH
BTO
Aug 27, 1996K960205CPR TRACHEOTOMY CARE TRAY
Custom Pack Reliability
BTO
Aug 15, 1996K962240MOORE TRACHEOSTOMY TUBE
Boston Medical Products, Inc.
BTO
May 16, 1996K953559LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
Seidel Medizin GmbH, DE
BTO
Aug 9, 1995K952416TRACHEOSTOMY CARE KIT
Medi-Flex Hospital Products, Inc.
BTO
Feb 27, 1995K945407SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
Mallinckrodt Medical Tpi, Inc.
BTO
Feb 27, 1995K945406SSV PHONATE(TM) SHILEY SPEAKING VALVE
Mallinckrodt Medical Tpi, Inc.
BTO
Feb 14, 1995K941470TRACHEOSTOMY CARE KIT
Clinical Resources, Inc.
BTO
Jun 16, 1993K924193TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
American Healthcare Corp.
BTO
Apr 2, 1993K924191TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
American Healthcare Corp.
BTO
Jan 6, 1993K924195TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
American Healthcare Corp.
BTO
Jan 6, 1993K924194TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
American Healthcare Corp.
BTO
Dec 10, 1992K923834TRACHEOSTOMY CARE SET WITH GLOVES
American Healthcare Corp.
BTO
Dec 3, 1992K925249CMI STOMA COVERS
Community Medical Center
BTO
Sep 2, 1992K922749LOW PROFILE TRACHEOSTOMY TUBE
Concord/Portex
BTO
Aug 27, 1992K921281TRACHEOSTOMY CARE KIT
Trinity Laboratories, Inc.
BTO
Aug 27, 1992K920281TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
Trinity Laboratories, Inc.
BTO
Jul 27, 1992K920604BIVONA TRACHEAL T-TUBE STENT
Bivona Medical Technologies
BTO
Jul 10, 1992K914743EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
Pertrach
BTO
Aug 16, 1991K912124TRACHEOSTOMY TUBE AND CUFF
Concord/Portex
BTO
Jun 19, 1991K912469BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
Bivona Medical Technologies
BTO
Sep 25, 1990K903730D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
Concord/Portex
BTO
Aug 17, 1990K901920PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
Primecare, Inc.
BTO
Aug 10, 1990K902281MODIFIED SCOOP TRANSTRACHEAL CATHETERS
Transtracheal Systems
BTO
May 18, 1990K901079SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
L H M Ent., Inc.
BTO
May 18, 1990K901078SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
L H M Ent., Inc.
BTO
Apr 23, 1990K900548SHILEY PHONATION VALVE
Shiley, Inc.
BTO

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