Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5750](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5750) → BSK — Cuff, Tracheal Tube, Inflatable # BSK · Cuff, Tracheal Tube, Inflatable _Anesthesiology · 21 CFR 868.5750 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK ## Overview - **Product Code:** BSK - **Device Name:** Cuff, Tracheal Tube, Inflatable - **Regulation:** [21 CFR 868.5750](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5750) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes - **Life-sustaining:** yes ## 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. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243562](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K243562.md) | CuffGuard | Idmed | Aug 12, 2025 | SESE | | [K242642](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K242642.md) | CuffTrek | Shanghai Longmann Tech Co., Ltd. | Mar 7, 2025 | SESE | | [K220854](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K220854.md) | TrachCuff Cuff Controller | Aw Technologies Aps | Apr 14, 2023 | SESE | | [K221477](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K221477.md) | AG100s | Hospitech Respiration , Ltd. | Dec 29, 2022 | SESE | | [K202874](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K202874.md) | Puritan Bennett Cuff Pressure Manager | Covidien, LLC | Jan 9, 2021 | SESE | | [K192611](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K192611.md) | Cuffix | Biovo Technologies , Ltd. | Aug 13, 2020 | SESE | | [K191858](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K191858.md) | Pylant Monitor | Kal-Med, LLC | Feb 24, 2020 | SESE | | [K182548](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K182548.md) | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | Jan 25, 2019 | SESE | | [K180991](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K180991.md) | AG 100s | Hospitech Respiration , Ltd. | Oct 12, 2018 | SESE | | [K173914](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K173914.md) | VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc. | May 25, 2018 | SESE | | [K152778](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K152778.md) | TRACOE Cuff Pressure Monitor | Tracoe Medical GmbH | Dec 21, 2016 | SESE | | [K152865](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K152865.md) | TRACOE smart Cuff Manager | Tracoe Medical GmbH | Sep 27, 2016 | SESE | | [K150157](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K150157.md) | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration , Ltd. | Feb 16, 2016 | SESE | | [K150893](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K150893.md) | IntelliCuff | Hamilton Medical AG | Jan 29, 2016 | SESE | | [K142103](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K142103.md) | CUFF PILOT, SURE SEAL | Teleflexmedical, Inc. | May 8, 2015 | SESE | | [K122721](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K122721.md) | AG GUFFILL | Hospitech Respiration , Ltd. | May 3, 2013 | SESE | | [K112915](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K112915.md) | SPIRTIUS CUFF INFLATION SYRINGE | Spiritus Technologies, LLC | May 25, 2012 | SESE | | [K113644](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K113644.md) | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | Jan 26, 2012 | SESE | | [K110631](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K110631.md) | VENNER TRACHEAL SEAL MONITOR | Venner Medical (Singapore) Pte, Ltd. | Jul 28, 2011 | SESE | | [K102674](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK/K102674.md) | CUFF SENTRY | Ventlab Corp. | Jul 22, 2011 | SESE | ## Top Applicants - Hospitech Respiration , Ltd. — 4 clearances - Instrumentation Industries, Inc. — 3 clearances - Tracoe Medical GmbH — 2 clearances - Arm Medical Devices, Inc. — 1 clearance - Aw Technologies Aps — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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