ClearanceBrief
Panels › Anesthesiology › Product code BSK · Class 2

Cuff, Tracheal Tube, Inflatable

Regulation 868.5750

1510(k)s in 12 months (40 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
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Top companies in BSK

Company510(k)sRecalls
Hospitech Respiration , Ltd.40
Hamilton Medical AG12
Instrumentation Industries, Inc.30
Aw Technologies Aps20
Covidien, LLC11
Tracoe Medical GmbH20
Arm Medical Devices, Inc.10
Bio-Med Devices, Inc.10
Biovo Technologies , Ltd.10
Dhd Medical Products Div. Diemolding Corp.10
Decided510(k)Device and applicantCode
Aug 13, 2026K261499TrachFlush
Aw Technologies Aps, DK
BSK
Aug 12, 2025K243562CuffGuard
Idmed, FR
BSK
Mar 7, 2025K242642CuffTrek
Shanghai Longmann Tech Co., Ltd., CN
BSK
Apr 14, 2023K220854TrachCuff Cuff Controller
Aw Technologies Aps, DK
BSK
Dec 29, 2022K221477AG100s
Hospitech Respiration , Ltd., IL
BSK
Jan 9, 2021K202874Puritan Bennett Cuff Pressure Manager
Covidien, LLC, CN
BSK
Aug 13, 2020K192611Cuffix
Biovo Technologies , Ltd., IL
BSK
Feb 24, 2020K191858Pylant Monitor
Kal-Med, LLC
BSK
Jan 25, 2019K182548Accucuff Cuff Pressure Indicator
Tianjin Medis Medical Device Co., Ltd., CN
BSK
Oct 12, 2018K180991AG 100s
Hospitech Respiration , Ltd., IL
BSK
May 25, 2018K173914VORTRAN Cuff Inflator (VCI)
Vortran Medical Technology 1, Inc.
BSK
Dec 21, 2016K152778TRACOE Cuff Pressure Monitor
Tracoe Medical GmbH, DE
BSK
Sep 27, 2016K152865TRACOE smart Cuff Manager
Tracoe Medical GmbH, DE
BSK
Feb 16, 2016K150157AnapnoGuard 100 Respiratory Guard System
Hospitech Respiration , Ltd., IL
BSK
Jan 29, 2016K150893IntelliCuff
Hamilton Medical AG, CH
BSK
May 8, 2015K142103CUFF PILOT, SURE SEAL
Teleflexmedical, Inc.
BSK
May 3, 2013K122721AG GUFFILL
Hospitech Respiration , Ltd., IL
BSK
May 25, 2012K112915SPIRTIUS CUFF INFLATION SYRINGE
Spiritus Technologies, LLC
BSK
Jan 26, 2012K113644PILOT TUBE REPAIR KIT
Instrumentation Industries, Inc.
BSK
Jul 28, 2011K110631VENNER TRACHEAL SEAL MONITOR
Venner Medical (Singapore) Pte, Ltd.
BSK
Jul 22, 2011K102674CUFF SENTRY
Ventlab Corp.
BSK
Mar 10, 2011K102704EASY CUFF
Joan Spiegel, MD
BSK
Feb 26, 2010K092733PYTON
Arm Medical Devices, Inc.
BSK
Nov 14, 2008K081805CUFFALERT
Sunmed
BSK
Dec 17, 1997K973755PILOT TUBE REPAIR KIT
Instrumentation Industries, Inc.
BSK
Apr 6, 1995K951046RUSCH ENDOTEST CUFF PRESSURE MONITOR
Rusch Intl.
BSK
Feb 26, 1993K923800PRESSURE GAUGE
Innovations For Mechanical Ventilation, Inc.
BSK
Aug 2, 1991K912352PEACE MODEL 100 CUFF MONITOR
Peace Medical, Inc.
BSK
Jul 20, 1991K912723POSEY CUFFLATOR
Posey Co.
BSK
Jul 18, 1990K902114CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR
Diemolding Corp.
BSK
Apr 26, 1990K900755DIGITAL CUFF PV GAUGE
International Medical Products, Inc.
BSK
Mar 28, 1990K901255CUFF BARO GUARD OR CBG ABBREVIATED
Nelson Engineering, Inc.
BSK
Mar 14, 1989K885216ATTACHABLE LANZ (TENTATIVE)
Mallinckroot, Inc.
BSK
Nov 23, 1988K884638BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
Instrumentation Industries, Inc.
BSK
Jun 16, 1988K881514PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM
Hall Laboratories, Inc.
BSK
Apr 14, 1988K881178CUFFCHECK
Dhd Medical Products Div. Diemolding Corp.
BSK
Jan 22, 1988K873614CBG CUFF MANOMETER
Bio-Med Devices, Inc.
BSK
Nov 28, 1983K833327RESPIRONICS PR VALVE
Respironics, Inc.
BSK
Jul 7, 1983K831577TRACHEA/CUFF INFLATOR W/PRESSURE #583
Medical Electronics Corp.
BSK
Nov 27, 1979K792265SHILEY PRESSURE RELIEF ADAPTER PRA
Shiley, Inc.
BSK

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