Cuff Sentry
510(k) K102674
Cuff Sentry is a medical device (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Ventlab Corp., cleared under FDA 510(k) K102674 on 22 Jul 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102674 | Date22 Jul 2011 | StatusActive |
Official records
- FDA 510(k) database K102674
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BSK
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5750
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K102674
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SunMed 4-0101-00 | 4-0101-00 / 4-0101-00 | 10889483002599 | — | On the market |
Similar devices
Other devices filed under FDA product code BSK (Cuff, Tracheal Tube, Inflatable).
- RUSCH ENDOTEST CUFF PRESSURE MONITOR by Rusch Intl.
- CUFF PILOT, SURE SEAL by Teleflex Medical, LLC
- PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM by Hall Laboratories, Inc.
- SPIRTIUS CUFF INFLATION SYRINGE by Spiritus Technologies, LLC
- TRACHEA/CUFF INFLATOR W/PRESSURE #583 by Medical Electronics Corp.
- CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR by Diemolding Corp.
- TrachCuff Cuff Controller by Aw Technologies Aps
- TRACOE Cuff Pressure Monitor by TRACOE MEDICAL GMBH
- VENNER TRACHEAL SEAL MONITOR by VENNER MEDICAL (SINGAPORE) PTE. LTD.
- DIGITAL CUFF PV GAUGE by International Medical Products, Inc.