BSK
39 FDA 510(k) clearances · Product code
146 daysmedian time to decision
363 days90th percentile
39clearances measured
FDA profile
- Official device name
- Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Medical specialty
- Anesthesiology
- Flags
- Life-sustaining · Third-party review eligible
- Adverse events (MAUDE)
- 2012: 62 · 2013: 16 · 2023: 51 · 2024: 133 · 2025: 46 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CuffGuard (K243562) | Idmed | 2025-08-12 |
| CuffTrek (K242642) | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 |
| TrachCuff Cuff Controller (K220854) | Aw Technologies Aps | 2023-04-14 |
| AG100s (K221477) | Hospitech Respiration , Ltd. | 2022-12-29 |
| Puritan Bennett Cuff Pressure Manager (K202874) | Covidien, LLC | 2021-01-09 |
| Cuffix (K192611) | Biovo Technologies , Ltd. | 2020-08-13 |
| Pylant Monitor (K191858) | Kal-Med, LLC | 2020-02-24 |
| Accucuff Cuff Pressure Indicator (K182548) | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 |
| AG 100s (K180991) | Hospitech Respiration , Ltd. | 2018-10-12 |
| VORTRAN Cuff Inflator (VCI) (K173914) | Vortran Medical Technology 1, Inc. | 2018-05-25 |
| TRACOE Cuff Pressure Monitor (K152778) | Tracoe Medical GmbH | 2016-12-21 |
| TRACOE smart Cuff Manager (K152865) | Tracoe Medical GmbH | 2016-09-27 |
| AnapnoGuard 100 Respiratory Guard System (K150157) | Hospitech Respiration , Ltd. | 2016-02-16 |
| IntelliCuff (K150893) | Hamilton Medical AG | 2016-01-29 |
| CUFF PILOT, SURE SEAL (K142103) | Teleflexmedical, Inc. | 2015-05-08 |
| AG GUFFILL (K122721) | Hospitech Respiration , Ltd. | 2013-05-03 |
| SPIRTIUS CUFF INFLATION SYRINGE (K112915) | Spiritus Technologies, LLC | 2012-05-25 |
| PILOT TUBE REPAIR KIT (K113644) | Instrumentation Industries, Inc. | 2012-01-26 |
| VENNER TRACHEAL SEAL MONITOR (K110631) | Venner Medical (Singapore) Pte, Ltd. | 2011-07-28 |
| CUFF SENTRY (K102674) | Ventlab Corp. | 2011-07-22 |
| EASY CUFF (K102704) | Joan Spiegel, MD | 2011-03-10 |
| PYTON (K092733) | Arm Medical Devices, Inc. | 2010-02-26 |
| CUFFALERT (K081805) | Sunmed | 2008-11-14 |
| PILOT TUBE REPAIR KIT (K973755) | Instrumentation Industries, Inc. | 1997-12-17 |
| RUSCH ENDOTEST CUFF PRESSURE MONITOR (K951046) | Rusch Intl. | 1995-04-06 |
| PRESSURE GAUGE (K923800) | Innovations For Mechanical Ventilation, Inc. | 1993-02-26 |
| PEACE MODEL 100 CUFF MONITOR (K912352) | Peace Medical, Inc. | 1991-08-02 |
| POSEY CUFFLATOR (K912723) | Posey Co. | 1991-07-20 |
| CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (K902114) | Diemolding Corp. | 1990-07-18 |
| DIGITAL CUFF PV GAUGE (K900755) | International Medical Products, Inc. | 1990-04-26 |
| CUFF BARO GUARD OR CBG ABBREVIATED (K901255) | Nelson Engineering, Inc. | 1990-03-28 |
| ATTACHABLE LANZ (TENTATIVE) (K885216) | Mallinckroot, Inc. | 1989-03-14 |
| BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR (K884638) | Instrumentation Industries, Inc. | 1988-11-23 |
| PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM (K881514) | Hall Laboratories, Inc. | 1988-06-16 |
| CUFFCHECK (K881178) | Dhd Medical Products Div. Diemolding Corp. | 1988-04-14 |
| CBG CUFF MANOMETER (K873614) | Bio-Med Devices, Inc. | 1988-01-22 |
| RESPIRONICS PR VALVE (K833327) | Respironics, Inc. | 1983-11-28 |
| TRACHEA/CUFF INFLATOR W/PRESSURE #583 (K831577) | Medical Electronics Corp. | 1983-07-07 |
| SHILEY PRESSURE RELIEF ADAPTER PRA (K792265) | Shiley, Inc. | 1979-11-27 |
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