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BTO — Tube, Tracheostomy (W/Wo Connector) Class II

FDA Device Classification

Classification Details

Product Code
BTO
Device Class
Class II
Regulation Number
868.5800
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242921vitaltec corporation5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes June 10, 2025
K233713teleflex medicalPilling Tracheostomy TubesMarch 22, 2024
K192511venner medical (singapore) pteVenner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (TracheostomyJuly 22, 2020
K173384smiths medical adsBLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrApril 10, 2018
K120079primed halberstadt medizintechnikPRIMED TRACHEOSTOMY TUBES (MULTIPLE)May 24, 2012
K101721regulatory and marketing servicesWELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAMarch 24, 2011
K100950venner medical (singapore) pteVENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEJuly 13, 2010
K100480vitaltec corporationROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACHJune 11, 2010
K100283cookVERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREApril 23, 2010
K083031smiths medical asdPORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITAugust 18, 2009
K073702lazarus medicalPHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTORJune 26, 2008
K062104engineered medical systemsTALKING TRACHApril 20, 2007
K060945smiths medical internationalPORTEX PERCUTANEOUS TRACHEOSTOMY KITJune 19, 2006
K051587tracoe medicalTRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465,October 25, 2005
K050379cs medicalCS MEDICAL ADULT TTCF CATHETERJuly 12, 2005
K042684well lead medical instrumentsWELL LEAD TRACHEOSTOMY TUBEFebruary 17, 2005
K031553arcadia medical corporationSILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC November 18, 2003
K030570portexBLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBESeptember 17, 2003
K030381portexPORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULAAugust 27, 2003
K021764rusch intlRUSCH TRACHEOFIX SET, CUFFED AND UNCUFFEDJuly 23, 2002