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Cuff, Tracheal Tube, Inflatable
FDA product code BSK · Class 2 · Anesthesiology
71
Registered devices
421
Adverse events
4
Recalls
40
510(k) clearances
Devices with this code
VCI (VORTRAN Cuff Inflator) — VORTRAN MEDICAL TECHNOLOGY 1, INCPOSEY — POSEY PRODUCTS, LLCAG Cuffill (mmHg) — HOSPITECH RESPIRATION LTDNA — Nuvasive, Inc.Puritan Bennett — Covidien LPAG Cuffill (cmH2O) — HOSPITECH RESPIRATION LTDRUSCH — TELEFLEX INCORPORATEDNA — Nuvasive, Inc.Ambu Cuff Pressure Gauge — Ambu A/SMedis — Tianjin Medis Medical Device Co.,Ltd.Puritan Bennett — Covidien LPVenner™ Tracheal Seal Monitor — VENNER MEDICAL (SINGAPORE) PTE. LTD.Cuffix — BIOVO TECHNOLOGIES LTDNA — Nuvasive, Inc.CuffGuard — IDMEDCuffGuard — IDMEDAG100s control unit — HOSPITECH RESPIRATION LTDTRACOE technic — Tracoe medical GmbHPylant Monitor — Kal-Med, LLCRUSCH — TELEFLEX INCORPORATEDTRACOE technic — Tracoe medical GmbHN/A — VBM Medizintechnik GmbHRUSCH — TELEFLEX INCORPORATEDPOSEY — POSEY PRODUCTS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | Hamilton Medical AG | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the |
| 2023-08-22 | Covidien | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device h |
| 2017-06-20 | Hamilton Medical, Inc. | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
| 2013-08-27 | H & H Associates | Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. |
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