TRACOE smart Cuff Manager
510(k) K152865
TRACOE smart Cuff Manager is a medical device (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Tracoe medical GmbH, cleared under FDA 510(k) K152865 on 27 Sep 2016, 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 | NumberK152865 | Date27 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K152865
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- Withdrawn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 K152865
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 | |||
|---|---|---|---|---|
| TRACOE technic REF 730-5 | REF 730-5 / REF 730-5 | 04035324019632 | — | On the market |
| TRACOE® technic REF 730 | REF 730 | 04035324019496 | — | No longer on the market |
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Other devices filed under FDA product code BSK (Cuff, Tracheal Tube, Inflatable).
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