BSK · Cuff, Tracheal Tube, Inflatable

Anesthesiology · 21 CFR 868.5750 · Class 2

Overview

Product CodeBSK
Device NameCuff, Tracheal Tube, Inflatable
Regulation21 CFR 868.5750
Device ClassClass 2
Review PanelAnesthesiology
3rd-Party ReviewableYes
Life-SustainingYes

Identification

An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 39)

Showing 20 most recent of 39 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K243562CuffGuardIdmedAug 12, 2025SESE
K242642CuffTrekShanghai Longmann Tech Co., Ltd.Mar 7, 2025SESE
K220854TrachCuff Cuff ControllerAw Technologies ApsApr 14, 2023SESE
K221477AG100sHospitech Respiration , Ltd.Dec 29, 2022SESE
K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLCJan 9, 2021SESE
K192611CuffixBiovo Technologies , Ltd.Aug 13, 2020SESE
K191858Pylant MonitorKal-Med, LLCFeb 24, 2020SESE
K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.Jan 25, 2019SESE
K180991AG 100sHospitech Respiration , Ltd.Oct 12, 2018SESE
K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc.May 25, 2018SESE
K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbHDec 21, 2016SESE
K152865TRACOE smart Cuff ManagerTracoe Medical GmbHSep 27, 2016SESE
K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration , Ltd.Feb 16, 2016SESE
K150893IntelliCuffHamilton Medical AGJan 29, 2016SESE
K142103CUFF PILOT, SURE SEALTeleflexmedical, Inc.May 8, 2015SESE
K122721AG GUFFILLHospitech Respiration , Ltd.May 3, 2013SESE
K112915SPIRTIUS CUFF INFLATION SYRINGESpiritus Technologies, LLCMay 25, 2012SESE
K113644PILOT TUBE REPAIR KITInstrumentation Industries, Inc.Jan 26, 2012SESE
K110631VENNER TRACHEAL SEAL MONITORVenner Medical (Singapore) Pte, Ltd.Jul 28, 2011SESE
K102674CUFF SENTRYVentlab Corp.Jul 22, 2011SESE

Top Applicants

Innolitics

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