Product code BSK
- Device name
- Cuff, Tracheal Tube, Inflatable
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5750
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243562 | CuffGuard | Idmed | 2025-08-12 |
| K242642 | CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 |
| K220854 | TrachCuff Cuff Controller | Aw Technologies Aps | 2023-04-14 |
| K221477 | AG100s | Hospitech Respiration , Ltd. | 2022-12-29 |
| K202874 | Puritan Bennett Cuff Pressure Manager | Covidien, LLC | 2021-01-09 |
| K192611 | Cuffix | Biovo Technologies , Ltd. | 2020-08-13 |
| K191858 | Pylant Monitor | Kal-Med, LLC | 2020-02-24 |
| K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 |
| K180991 | AG 100s | Hospitech Respiration , Ltd. | 2018-10-12 |
| K173914 | VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc. | 2018-05-25 |
| K152778 | TRACOE Cuff Pressure Monitor | Tracoe Medical GmbH | 2016-12-21 |
| K152865 | TRACOE smart Cuff Manager | Tracoe Medical GmbH | 2016-09-27 |
| K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration , Ltd. | 2016-02-16 |
| K150893 | IntelliCuff | Hamilton Medical AG | 2016-01-29 |
| K142103 | CUFF PILOT, SURE SEAL | Teleflexmedical, Inc. | 2015-05-08 |
| K122721 | AG GUFFILL | Hospitech Respiration , Ltd. | 2013-05-03 |
| K112915 | SPIRTIUS CUFF INFLATION SYRINGE | Spiritus Technologies, LLC | 2012-05-25 |
| K113644 | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | 2012-01-26 |
| K110631 | VENNER TRACHEAL SEAL MONITOR | Venner Medical (Singapore) Pte, Ltd. | 2011-07-28 |
| K102674 | CUFF SENTRY | Ventlab Corp. | 2011-07-22 |
| K102704 | EASY CUFF | Joan Spiegel, MD | 2011-03-10 |
| K092733 | PYTON | Arm Medical Devices, Inc. | 2010-02-26 |
| K081805 | CUFFALERT | Sunmed | 2008-11-14 |
| K973755 | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | 1997-12-17 |
| K951046 | RUSCH ENDOTEST CUFF PRESSURE MONITOR | Rusch Intl. | 1995-04-06 |
| K912352 | PEACE MODEL 100 CUFF MONITOR | Peace Medical, Inc. | 1991-08-02 |
| K912723 | POSEY CUFFLATOR | Posey Co. | 1991-07-20 |
| K902114 | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR | Diemolding Corp. | 1990-07-18 |
| K900755 | DIGITAL CUFF PV GAUGE | International Medical Products, Inc. | 1990-04-26 |
| K901255 | CUFF BARO GUARD OR CBG ABBREVIATED | Nelson Engineering, Inc. | 1990-03-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16979264200000 | CuffTrek | SHANGHAI LONGMANN TECH CO.,LTD. | 2026-02-12 |
| 03665023001112 | CuffGuard | IDMED | 2025-12-19 |
| 10197344118441 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-13 |
| 10197344118458 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-13 |
| 10618125191533 | Posey | TIDI PRODUCTS, LLC | 2024-05-03 |
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 10190676008039 | POSEY | POSEY PRODUCTS, LLC | 2023-01-25 |
| 10884521782495 | Puritan Bennett | Covidien LP | 2021-06-18 |
| 10884521782501 | Puritan Bennett | Covidien LP | 2021-06-07 |
| B00500197TUBING3 | AincA® | ANESTHESIA ASSOCIATES, INC. | 2021-03-31 |
| 00887517163226 | NA | Nuvasive, Inc. | 2019-11-12 |
| 00887517163219 | NA | Nuvasive, Inc. | 2019-11-12 |
| 00887517163233 | NA | Nuvasive, Inc. | 2019-11-12 |
| 34026704630517 | RUSCH | TELEFLEX INCORPORATED | 2019-04-30 |
| 14026704640741 | RUSCH | TELEFLEX INCORPORATED | 2019-04-24 |
| 10637320024507 | VCI (VORTRAN Cuff Inflator) | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2018-08-31 |
| 14250105628095 | Ambu A/S | VBM Medizintechnik GmbH | 2018-03-26 |
| 00887517161390 | NA | Nuvasive, Inc. | 2016-09-26 |
| 00887517161383 | NA | Nuvasive, Inc. | 2016-09-26 |
| 14250105622437 | RÜSCH | VBM Medizintechnik GmbH | 2016-01-17 |
| 14250105605720 | N/A | VBM Medizintechnik GmbH | 2016-01-17 |
| 14250105600510 | NA | VBM Medizintechnik GmbH | 2016-01-17 |
| 14250105600480 | N/A | VBM Medizintechnik GmbH | 2016-01-17 |
| 14250105600473 | N/A | VBM Medizintechnik GmbH | 2016-01-17 |
| 14250105600466 | N/A | VBM Medizintechnik GmbH | 2016-01-17 |
| 24026704008548 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 04026704034543 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 10351688517166 | Portex | ICU MEDICAL, INC. | 2015-08-07 |
| M996BE4090 | Pilot Tube Repair Kit | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-07-31 |
| 10351688517173 | Medex | ICU MEDICAL, INC. | 2015-07-29 |