Cuff, Tracheal Tube, Inflatable
FDA product code BSK · Class II (moderate risk) · 21 CFR 868.5750 · Anesthesiology
40510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Hospitech Respiration , Ltd. 4
- Instrumentation Industries, Inc. 3
- Tracoe Medical GmbH 2
- Aw Technologies Aps 2
- Diemolding Corp. 1
- Ventlab Corp. 1
- Joan Spiegel, MD 1
- Sunmed, Inc. 1
- Rusch Intl. 1
- Innovations For Mechanical Ventilation, Inc. 1
- Peace Medical, Inc. 1
- Posey Co. 1
- Shiley, Inc. 1
- Idmed 1
- Nelson Engineering, Inc. 1
- Mallinckroot, Inc. 1
- Hall Laboratories, Inc. 1
- Dhd Medical Products Div. Diemolding Corp. 1
- Bio-Med Devices, Inc. 1
- Respironics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261499 | TrachFlushBSK · Traditional | Aw Technologies Aps | 08/13/2026SE |
| K243562 | CuffGuardBSK · Traditional | Idmed | 08/12/2025SE |
| K242642 | CuffTrekBSK · Traditional | Shanghai Longmann Tech Co., Ltd. | 03/07/2025SE |
| K220854 | TrachCuff Cuff ControllerBSK · Traditional | Aw Technologies Aps | 04/14/2023SE |
| K221477 | AG100sBSK · Traditional | Hospitech Respiration , Ltd. | 12/29/2022SE |
| K202874 | Puritan Bennett Cuff Pressure ManagerBSK · Traditional | Covidien, LLC | 01/09/2021SE |
| K192611 | CuffixBSK · Traditional | Biovo Technologies , Ltd. | 08/13/2020SE |
| K191858 | Pylant MonitorBSK · Traditional | Kal-Med, LLC | 02/24/2020SE |
| K182548 | Accucuff Cuff Pressure IndicatorBSK · Traditional | Tianjin Medis Medical Device Co., Ltd. | 01/25/2019SE |
| K180991 | AG 100sBSK · Traditional | Hospitech Respiration , Ltd. | 10/12/2018SE |
| K173914 | VORTRAN Cuff Inflator (VCI)BSK · Traditional | Vortran Medical Technology 1, Inc. | 05/25/2018SE |
| K152778 | TRACOE Cuff Pressure MonitorBSK · Traditional | Tracoe Medical GmbH | 12/21/2016SE |
| K152865 | TRACOE smart Cuff ManagerBSK · Traditional | Tracoe Medical GmbH | 09/27/2016SE |
| K150157 | AnapnoGuard 100 Respiratory Guard SystemBSK · Traditional | Hospitech Respiration , Ltd. | 02/16/2016SE |
| K150893 | IntelliCuffBSK · Traditional | Hamilton Medical AG | 01/29/2016SE |
| K142103 | Cuff Pilot, Sure SealBSK · Traditional | Teleflexmedical, Inc. | 05/08/2015SE |
| K122721 | AG GuffillBSK · Traditional | Hospitech Respiration , Ltd. | 05/03/2013SE |
| K112915 | Spirtius Cuff Inflation SyringeBSK · Traditional | Spiritus Technologies, LLC | 05/25/2012SE |
| K113644 | Pilot Tube Repair KitBSK · Special | Instrumentation Industries, Inc. | 01/26/2012SE |
| K110631 | Venner Tracheal Seal MonitorBSK · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/28/2011SE |
| K102674 | Cuff SentryBSK · Traditional | Ventlab Corp. | 07/22/2011SE |
| K102704 | Easy CuffBSK · Traditional | Joan Spiegel, MD | 03/10/2011SE |
| K092733 | PytonBSK · Traditional | Arm Medical Devices, Inc. | 02/26/2010SE |
| K081805 | CuffalertBSK · Traditional | Sunmed | 11/14/2008SE |
| K973755 | Pilot Tube Repair KitBSK · Traditional | Instrumentation Industries, Inc. | 12/17/1997SE |
| K951046 | Rusch Endotest Cuff Pressure MonitorBSK · Traditional | Rusch Intl. | 04/06/1995SE |
| K923800 | Pressure GaugeBSK · Traditional | Innovations For Mechanical Ventilation, Inc. | 02/26/1993SE |
| K912352 | Peace Model 100 Cuff MonitorBSK · Traditional | Peace Medical, Inc. | 08/02/1991SE |
| K912723 | Posey CufflatorBSK · Traditional | Posey Co. | 07/20/1991SE |
| K902114 | Cuff-Mate 2 Endotracheal Cuff Inflator & MonitorBSK · Traditional | Diemolding Corp. | 07/18/1990SE |
| K900755 | Digital Cuff PV GaugeBSK · Traditional | International Medical Products, Inc. | 04/26/1990SE |
| K901255 | Cuff Baro Guard or CBG AbbreviatedBSK · Traditional | Nelson Engineering, Inc. | 03/28/1990SE |
| K885216 | Attachable Lanz (Tentative)BSK · Traditional | Mallinckroot, Inc. | 03/14/1989SE |
| K884638 | Be 410 Endotracheal Tube/Trach Tube, Pilot RepairBSK · Traditional | Instrumentation Industries, Inc. | 11/23/1988SE |
| K881514 | Pristine Specimen Tube and Introducer SystemBSK · Traditional | Hall Laboratories, Inc. | 06/16/1988SE |
| K881178 | CuffcheckBSK · Traditional | Dhd Medical Products Div. Diemolding Corp. | 04/14/1988SE |
| K873614 | CBG Cuff ManometerBSK · Traditional | Bio-Med Devices, Inc. | 01/22/1988SE |
| K833327 | Respironics PR ValveBSK · Traditional | Respironics, Inc. | 11/28/1983SE |
| K831577 | Trachea/Cuff Inflator W/Pressure #583BSK · Traditional | Medical Electronics Corp. | 07/07/1983SE |
| K792265 | Shiley Pressure Relief Adapter PraBSK · Traditional | Shiley, Inc. | 11/27/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2625-2026 Class II | IntelliCuff, Portable automatic cuff pressure controller REF: 951001Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the… | Hamilton Medical AG | 05/22/2026Open, Classified |
| Z-2651-2023 Class II | Puritan Bennett Cuff Pressure Manager, REF: 180-03Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external… | Covidien | 08/22/2023Open, Classified |
| Z-0335-2018 Class II | Intellicuff Standalone (PN 951001) Used to continuously measure and automatically…Issue related to the performance of the motor in recalled product. During use, motor may cease to function. | Hamilton Medical, Inc. | 06/20/2017Open, Classified |
| Z-0006-2014 Class I | H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692)…Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. | H & H Associates | 08/27/2013Terminated |