FDA 510(k) Applications for Medical Device Product Code "BSK"
(Cuff, Tracheal Tube, Inflatable)

FDA 510(k) Number Applicant Device Name Decision Date
K092733 ARM MEDICAL DEVICES, INC. PYTON 02/26/2010
K873614 BIO-MED DEVICES, INC. CBG CUFF MANOMETER 01/22/1988
K881178 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. CUFFCHECK 04/14/1988
K902114 DIEMOLDING CORP. CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR 07/18/1990
K881514 HALL LABORATORIES, INC. PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM 06/16/1988
K150893 HAMILTON MEDICAL AG IntelliCuff 01/29/2016
K122721 HOSPITECH RESPIRATION LTD. AG GUFFILL 05/03/2013
K150157 HOSPITECH RESPIRATION LTD. AnapnoGuard 100 Respiratory Guard System 02/16/2016
K923800 INNOVATIONS FOR MECHANICAL VENTILATION, INC. PRESSURE GAUGE 02/26/1993
K884638 INSTRUMENTATION INDUSTRIES, INC. BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR 11/23/1988
K113644 INSTRUMENTATION INDUSTRIES, INC. PILOT TUBE REPAIR KIT 01/26/2012
K973755 INSTRUMENTATION INDUSTRIES, INC. PILOT TUBE REPAIR KIT 12/17/1997
K900755 INTERNATIONAL MEDICAL PRODUCTS, INC. DIGITAL CUFF PV GAUGE 04/26/1990
K102704 JOAN SPIEGEL, MD EASY CUFF 03/10/2011
K885216 MALLINCKROOT, INC. ATTACHABLE LANZ (TENTATIVE) 03/14/1989
K831577 MEDICAL ELECTRONICS CORP. TRACHEA/CUFF INFLATOR W/PRESSURE #583 07/07/1983
K901255 NELSON ENGINEERING, INC. CUFF BARO GUARD OR CBG ABBREVIATED 03/28/1990
K912352 PEACE MEDICAL, INC. PEACE MODEL 100 CUFF MONITOR 08/02/1991
K912723 POSEY CO. POSEY CUFFLATOR 07/20/1991
K833327 RESPIRONICS, INC. RESPIRONICS PR VALVE 11/28/1983
K951046 RUSCH INTL. RUSCH ENDOTEST CUFF PRESSURE MONITOR 04/06/1995
K792265 SHILEY, INC. SHILEY PRESSURE RELIEF ADAPTER "PRA" 11/27/1979
K112915 SPIRITUS TECHNOLOGIES LLC SPIRTIUS CUFF INFLATION SYRINGE 05/25/2012
K081805 SUNMED CUFFALERT 11/14/2008
K142103 Teleflex Medical, Inc. CUFF PILOT, SURE SEAL 05/08/2015
K152778 TRACOE MEDICAL GMBH TRACOE Cuff Pressure Monitor 12/21/2016
K152865 TRACOE MEDICAL GMBH TRACOE smart Cuff Manager 09/27/2016
K110631 VENNER MEDICAL (SINGAPORE) PTE LTD VENNER TRACHEAL SEAL MONITOR 07/28/2011
K102674 VENTLAB CORP. CUFF SENTRY 07/22/2011
K173914 VORTRAN Medical Technology 1, Inc. VORTRAN Cuff Inflator (VCI) 05/25/2018


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