Panels › Anesthesiology › Product code BSK · Class 2
Cuff, Tracheal Tube, Inflatable
Regulation 868.5750
1510(k)s in 12 months (40 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in BSK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hospitech Respiration , Ltd. | 4 | 0 |
| Hamilton Medical AG | 1 | 2 |
| Instrumentation Industries, Inc. | 3 | 0 |
| Aw Technologies Aps | 2 | 0 |
| Covidien, LLC | 1 | 1 |
| Tracoe Medical GmbH | 2 | 0 |
| Arm Medical Devices, Inc. | 1 | 0 |
| Bio-Med Devices, Inc. | 1 | 0 |
| Biovo Technologies , Ltd. | 1 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Hamilton Medical AG IntelliCuff, Portable automatic cuff pressure controller
REF: 951001 Open, Classified |
BSK | K150893 |
| Sep 29, 2023 | Covidien Puritan Bennett Cuff Pressure Manager, REF: 180-03 Open, Classified |
BSK | K202874 |
| Jun 20, 2017 | Hamilton Medical, Inc. Intellicuff Standalone (PN 951001)
Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used Open, Classified |
BSK | K150893 |
| Oct 1, 2013 | H & H Associates H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.c Terminated |
BSK | None listed |
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