BSK · Class II · 21 CFR 868.5750

FDA Product Code BSK: Cuff, Tracheal Tube, Inflatable

Leading manufacturers include Hospitech Respiration , Ltd., Instrumentation Industries, Inc. and Aw Technologies Aps.

40
Total
40
Cleared
164d
Avg days
1979
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 184d avg (recent)

FDA 510(k) Cleared Cuff, Tracheal Tube, Inflatable Devices (Product Code BSK)

40 devices
1–24 of 40
Cleared Aug 13, 2026
TrachFlush
K261499
Aw Technologies Aps
Anesthesiology · 99d
Cleared Aug 12, 2025
CuffGuard
K243562
Idmed
Anesthesiology · 267d
Cleared Mar 07, 2025
CuffTrek
K242642
Shanghai Longmann Tech Co., Ltd.
Anesthesiology · 185d
Cleared Apr 14, 2023
TrachCuff Cuff Controller
K220854
Aw Technologies Aps
Anesthesiology · 387d
Cleared Dec 29, 2022
AG100s
K221477
Hospitech Respiration , Ltd.
Anesthesiology · 220d
Cleared Jan 09, 2021
Puritan Bennett Cuff Pressure Manager
K202874
Covidien, LLC
Anesthesiology · 103d
Cleared Aug 13, 2020
Cuffix
K192611
Biovo Technologies , Ltd.
Anesthesiology · 328d
Cleared Feb 24, 2020
Pylant Monitor
K191858
Kal-Med, LLC
Anesthesiology · 228d
Cleared Jan 25, 2019
Accucuff Cuff Pressure Indicator
K182548
Tianjin Medis Medical Device Co., Ltd.
Anesthesiology · 130d
Cleared Oct 12, 2018
AG 100s
K180991
Hospitech Respiration , Ltd.
Anesthesiology · 179d
Cleared May 25, 2018
VORTRAN Cuff Inflator (VCI)
K173914
Vortran Medical Technology 1, Inc.
Anesthesiology · 154d
Cleared Dec 21, 2016
TRACOE Cuff Pressure Monitor
K152778
Tracoe Medical GmbH
Anesthesiology · 453d
Cleared Sep 27, 2016
TRACOE smart Cuff Manager
K152865
Tracoe Medical GmbH
Anesthesiology · 363d
Cleared Feb 16, 2016
AnapnoGuard 100 Respiratory Guard System
K150157
Hospitech Respiration , Ltd.
Anesthesiology · 389d
Cleared Jan 29, 2016
IntelliCuff
K150893
Hamilton Medical AG
Anesthesiology · 302d
Cleared May 08, 2015
CUFF PILOT, SURE SEAL
K142103
Teleflexmedical, Inc.
Anesthesiology · 280d
Cleared May 03, 2013
AG GUFFILL
K122721
Hospitech Respiration , Ltd.
Anesthesiology · 240d
Cleared May 25, 2012
SPIRTIUS CUFF INFLATION SYRINGE
K112915
Spiritus Technologies, LLC
Anesthesiology · 235d
Cleared Jan 26, 2012
PILOT TUBE REPAIR KIT
K113644
Instrumentation Industries, Inc.
Anesthesiology · 45d
Cleared Jul 28, 2011
VENNER TRACHEAL SEAL MONITOR
K110631
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 146d
Cleared Jul 22, 2011
CUFF SENTRY
K102674
Ventlab Corp.
Anesthesiology · 309d
Cleared Mar 10, 2011
EASY CUFF
K102704
Joan Spiegel, MD
Anesthesiology · 171d
Cleared Feb 26, 2010
PYTON
K092733
Arm Medical Devices, Inc.
Anesthesiology · 175d
Cleared Nov 14, 2008
CUFFALERT
K081805
Sunmed
Anesthesiology · 141d

About Product Code BSK - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code BSK since 1979, with 40 receiving FDA clearance (average review time: 164 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BSK Product Code

FDA review times for BSK submissions have been consistent, averaging 184 days recently vs 162 days historically.

BSK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →