BSK · Class II · 21 CFR 868.5750

FDA Product Code BSK: Cuff, Tracheal Tube, Inflatable

Leading manufacturers include Instrumentation Industries, Inc., Hospitech Respiration , Ltd. and Kal-Med, LLC.

39
Total
39
Cleared
166d
Avg days
1979
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 226d recently vs 162d historically

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

39 devices
1–24 of 39
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 Jan 29, 2016
IntelliCuff
K150893
Hamilton Medical AG
Anesthesiology · 302d
Cleared May 08, 2015
CUFF PILOT, SURE SEAL
K142103
Teleflexmedical, Inc.
Anesthesiology · 280d
Cleared Jan 26, 2012
PILOT TUBE REPAIR KIT
K113644
Instrumentation Industries, Inc.
Anesthesiology · 45d
Cleared Dec 17, 1997
PILOT TUBE REPAIR KIT
K973755
Instrumentation Industries, Inc.
Anesthesiology · 76d
Cleared Apr 06, 1995
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046
Rusch Intl.
Anesthesiology · 31d
Cleared Nov 23, 1988
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638
Instrumentation Industries, Inc.
Anesthesiology · 16d
Cleared Apr 14, 1988
CUFFCHECK
K881178
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 27d
Cleared Nov 28, 1983
RESPIRONICS PR VALVE
K833327
Respironics, Inc.
Anesthesiology · 62d
Cleared Nov 27, 1979
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265
Shiley, Inc.
Anesthesiology · 18d

About Product Code BSK - Regulatory Context

510(k) Submission Activity

39 total 510(k) submissions under product code BSK since 1979, with 39 receiving FDA clearance (average review time: 166 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - BSK Product Code

Recent submissions under BSK have taken an average of 226 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.

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