Cuffalert
by SunMed
510(k) K081805
Cuffalert is a medical device (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by SunMed, cleared under FDA 510(k) K081805 on 14 Nov 2008, 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 | NumberK081805 | Date14 Nov 2008 | StatusActive |
Official records
- FDA 510(k) database K081805
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- Withdrawn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
Similar devices
Other devices filed under FDA product code BSK (Cuff, Tracheal Tube, Inflatable).
- 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.
- Pylant Monitor by KAL-MED, LLC.
- Cuffix by Biovo Technologies, Ltd.
- VORTRAN Cuff Inflator (VCI) by Vortran Medical Technology 1 Inc.