Product Code: BSK FDA class 2 21 CFR 868.5750

Cuff, Tracheal Tube, Inflatable

Anesthesiology

The Cuff, Tracheal Tube, Inflatable is an inflatable balloon cuff attached to a tracheal tube that, when inflated, seals the airway to prevent aspiration and ensure delivery of mechanical ventilation. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BSK, regulated under 21 CFR 868.5750 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: BSK
Device Class: FDA class 2
Regulation Number: 868.5750
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243562	CuffGuard	Aug 12, 2025	Substantially Equivalent	Idmed
K242642	CuffTrek	Mar 07, 2025	Substantially Equivalent	Shanghai Longmann Tech Co., Ltd.
K220854	TrachCuff Cuff Controller	Apr 14, 2023	Substantially Equivalent	Aw Technologies Aps
K221477	AG100s	Dec 29, 2022	Substantially Equivalent	Hospitech Respiration , Ltd.
K202874	Puritan Bennett Cuff Pressure Manager	Jan 09, 2021	Substantially Equivalent	Covidien, LLC
K192611	Cuffix	Aug 13, 2020	Substantially Equivalent	Biovo Technologies , Ltd.
K191858	Pylant Monitor	Feb 24, 2020	Substantially Equivalent	Kal-Med, LLC
K182548	Accucuff Cuff Pressure Indicator	Jan 25, 2019	Substantially Equivalent	Tianjin Medis Medical Device Co., Ltd.
K180991	AG 100s	Oct 12, 2018	Substantially Equivalent	Hospitech Respiration , Ltd.
K173914	VORTRAN Cuff Inflator (VCI)	May 25, 2018	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K152778	TRACOE Cuff Pressure Monitor	Dec 21, 2016	Substantially Equivalent	Tracoe Medical GmbH
K152865	TRACOE smart Cuff Manager	Sep 27, 2016	Substantially Equivalent	Tracoe Medical GmbH
K150157	AnapnoGuard 100 Respiratory Guard System	Feb 16, 2016	Substantially Equivalent	Hospitech Respiration , Ltd.
K150893	IntelliCuff	Jan 29, 2016	Substantially Equivalent	Hamilton Medical AG
K142103	CUFF PILOT, SURE SEAL	May 08, 2015	Substantially Equivalent	Teleflexmedical, Inc.
K122721	AG GUFFILL	May 03, 2013	Substantially Equivalent	Hospitech Respiration , Ltd.
K112915	SPIRTIUS CUFF INFLATION SYRINGE	May 25, 2012	Substantially Equivalent	Spiritus Technologies, LLC
K113644	PILOT TUBE REPAIR KIT	Jan 26, 2012	Substantially Equivalent	Instrumentation Industries, Inc.
K110631	VENNER TRACHEAL SEAL MONITOR	Jul 28, 2011	Substantially Equivalent	Venner Medical (Singapore) Pte, Ltd.
K102674	CUFF SENTRY	Jul 22, 2011	Substantially Equivalent	Ventlab Corp.
K102704	EASY CUFF	Mar 10, 2011	Substantially Equivalent	Joan Spiegel, MD
K092733	PYTON	Feb 26, 2010	Substantially Equivalent	Arm Medical Devices, Inc.
K081805	CUFFALERT	Nov 14, 2008	Substantially Equivalent	Sunmed
K973755	PILOT TUBE REPAIR KIT	Dec 17, 1997	Substantially Equivalent	Instrumentation Industries, Inc.
K951046	RUSCH ENDOTEST CUFF PRESSURE MONITOR	Apr 06, 1995	Substantially Equivalent	Rusch Intl.
K923800	PRESSURE GAUGE	Feb 26, 1993	Substantially Equivalent	Innovations For Mechanical Ventilation, Inc.
K912352	PEACE MODEL 100 CUFF MONITOR	Aug 02, 1991	Substantially Equivalent	Peace Medical, Inc.
K912723	POSEY CUFFLATOR	Jul 20, 1991	Substantially Equivalent	Posey Co.
K902114	CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR	Jul 18, 1990	Substantially Equivalent	Diemolding Corp.
K900755	DIGITAL CUFF PV GAUGE	Apr 26, 1990	Substantially Equivalent	International Medical Products, Inc.
K901255	CUFF BARO GUARD OR CBG ABBREVIATED	Mar 28, 1990	Substantially Equivalent	Nelson Engineering, Inc.
K885216	ATTACHABLE LANZ (TENTATIVE)	Mar 14, 1989	Substantially Equivalent	Mallinckroot, Inc.
K884638	BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR	Nov 23, 1988	Substantially Equivalent	Instrumentation Industries, Inc.
K881514	PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM	Jun 16, 1988	Substantially Equivalent	Hall Laboratories, Inc.
K881178	CUFFCHECK	Apr 14, 1988	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K873614	CBG CUFF MANOMETER	Jan 22, 1988	Substantially Equivalent	Bio-Med Devices, Inc.
K833327	RESPIRONICS PR VALVE	Nov 28, 1983	Substantially Equivalent	Respironics, Inc.
K831577	TRACHEA/CUFF INFLATOR W/PRESSURE #583	Jul 07, 1983	Substantially Equivalent	Medical Electronics Corp.
K792265	SHILEY PRESSURE RELIEF ADAPTER PRA	Nov 27, 1979	Substantially Equivalent	Shiley, Inc.