Cuff, Tracheal Tube, Inflatable

FDA product code BSK · 39 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5750
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: Yes
GMP exempt: No
Clearance span: 1979-11-27 – 2026-08-13

BSK 2026-08-13

TrachFlush

Applicant Aw Technologies Aps

K number K261499

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BSK 2025-08-12

CuffGuard

Applicant Idmed

K number K243562

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BSK 2025-03-07

CuffTrek

Applicant Shanghai Longmann Tech Co., Ltd.

K number K242642

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BSK 2023-04-14

TrachCuff Cuff Controller

Applicant Aw Technologies Aps

K number K220854

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BSK 2022-12-29

AG100s

Applicant Hospitech Respiration , Ltd.

K number K221477

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BSK 2021-01-09

Puritan Bennett Cuff Pressure Manager

Applicant Covidien, LLC

K number K202874

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BSK 2020-08-13

Cuffix

Applicant Biovo Technologies , Ltd.

K number K192611

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BSK 2020-02-24

Pylant Monitor

Applicant Kal-Med, LLC

K number K191858

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BSK 2019-01-25

Accucuff Cuff Pressure Indicator

Applicant Tianjin Medis Medical Device Co., Ltd.

K number K182548

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BSK 2018-10-12

AG 100s

Applicant Hospitech Respiration , Ltd.

K number K180991

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BSK 2018-05-25

VORTRAN Cuff Inflator (VCI)

Applicant Vortran Medical Technology 1, Inc.

K number K173914

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BSK 2016-12-21

TRACOE Cuff Pressure Monitor

Applicant Tracoe Medical GmbH

K number K152778

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BSK 2016-09-27

TRACOE smart Cuff Manager

Applicant Tracoe Medical GmbH

K number K152865

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BSK 2016-02-16

AnapnoGuard 100 Respiratory Guard System

Applicant Hospitech Respiration , Ltd.

K number K150157

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BSK 2016-01-29

IntelliCuff

Applicant Hamilton Medical AG

K number K150893

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BSK 2013-05-03

AG GUFFILL

Applicant Hospitech Respiration , Ltd.

K number K122721

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BSK 2012-05-25

SPIRTIUS CUFF INFLATION SYRINGE

Applicant Spiritus Technologies, LLC

K number K112915

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BSK 2012-01-26

PILOT TUBE REPAIR KIT

Applicant Instrumentation Industries, Inc.

K number K113644

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BSK 2011-07-28

VENNER TRACHEAL SEAL MONITOR

Applicant Venner Medical (Singapore) Pte, Ltd.

K number K110631

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BSK 2011-07-22

CUFF SENTRY

Applicant Ventlab Corp.

K number K102674

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BSK 2011-03-10

EASY CUFF

Applicant Joan Spiegel, MD

K number K102704

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BSK 2010-02-26

PYTON

Applicant Arm Medical Devices, Inc.

K number K092733

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BSK 2008-11-14

CUFFALERT

Applicant Sunmed

K number K081805

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BSK 1997-12-17

PILOT TUBE REPAIR KIT

Applicant Instrumentation Industries, Inc.

K number K973755

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BSK 1995-04-06

RUSCH ENDOTEST CUFF PRESSURE MONITOR

Applicant Rusch Intl.

K number K951046

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BSK 1993-02-26

PRESSURE GAUGE

Applicant Innovations For Mechanical Ventilation, Inc.

K number K923800

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BSK 1991-08-02

PEACE MODEL 100 CUFF MONITOR

Applicant Peace Medical, Inc.

K number K912352

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BSK 1991-07-20

POSEY CUFFLATOR

Applicant Posey Co.

K number K912723

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BSK 1990-07-18

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR

Applicant Diemolding Corp.

K number K902114

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BSK 1990-04-26

DIGITAL CUFF PV GAUGE

Applicant International Medical Products, Inc.

K number K900755

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BSK 1990-03-28

CUFF BARO GUARD OR CBG ABBREVIATED

Applicant Nelson Engineering, Inc.

K number K901255

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BSK 1989-03-14

ATTACHABLE LANZ (TENTATIVE)

Applicant Mallinckroot, Inc.

K number K885216

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BSK 1988-11-23

BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR

Applicant Instrumentation Industries, Inc.

K number K884638

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BSK 1988-06-16

PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM

Applicant Hall Laboratories, Inc.

K number K881514

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BSK 1988-04-14

CUFFCHECK

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K881178

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BSK 1988-01-22

CBG CUFF MANOMETER

Applicant Bio-Med Devices, Inc.

K number K873614

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BSK 1983-11-28

RESPIRONICS PR VALVE

Applicant Respironics, Inc.

K number K833327

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BSK 1983-07-07

TRACHEA/CUFF INFLATOR W/PRESSURE #583

Applicant Medical Electronics Corp.

K number K831577

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BSK 1979-11-27

SHILEY PRESSURE RELIEF ADAPTER PRA

Applicant Shiley, Inc.

K number K792265

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