BSK — Cuff, Tracheal Tube, Inflatable Class II
FDA product code BSK covers "Cuff, Tracheal Tube, Inflatable", a Class II medical device regulated under 21 CFR 868.5750. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BSK
- Device Class
- Class II
- Regulation Number
- 868.5750
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243562 | idmed | CuffGuard | August 12, 2025 |
| K242642 | shanghai longmann tech co | CuffTrek | March 7, 2025 |
| K220854 | aw technologies aps | TrachCuff Cuff Controller | April 14, 2023 |
| K221477 | hospitech respiration | AG100s | December 29, 2022 |
| K202874 | covidien | Puritan Bennett Cuff Pressure Manager | January 9, 2021 |
| K192611 | biovo technologies | Cuffix | August 13, 2020 |
| K191858 | kal-med | Pylant Monitor | February 24, 2020 |
| K182548 | tianjin medis medical device co | Accucuff Cuff Pressure Indicator | January 25, 2019 |
| K180991 | hospitech respiration | AG 100s | October 12, 2018 |
| K173914 | vortran medical technology 1 | VORTRAN Cuff Inflator (VCI) | May 25, 2018 |
| K152778 | tracoe medical | TRACOE Cuff Pressure Monitor | December 21, 2016 |
| K152865 | tracoe medical | TRACOE smart Cuff Manager | September 27, 2016 |
| K150157 | hospitech respiration | AnapnoGuard 100 Respiratory Guard System | February 16, 2016 |
| K150893 | hamilton medical | IntelliCuff | January 29, 2016 |
| K142103 | teleflexmedical | CUFF PILOT, SURE SEAL | May 8, 2015 |
| K122721 | hospitech respiration | AG GUFFILL | May 3, 2013 |
| K112915 | spiritus technologies | SPIRTIUS CUFF INFLATION SYRINGE | May 25, 2012 |
| K113644 | instrumentation industries | PILOT TUBE REPAIR KIT | January 26, 2012 |
| K110631 | venner medical (singapore) pte | VENNER TRACHEAL SEAL MONITOR | July 28, 2011 |
| K102674 | ventlab | CUFF SENTRY | July 22, 2011 |