APEX Compounding System Transfer Set
510(k) K151423
APEX Compounding System Transfer Set is a Class II device made by B. Braun Medical, Inc., cleared under FDA 510(k) K151423 on 19 Feb 2016, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151423 | Date19 Feb 2016 | StatusActive |
Official records
- FDA 510(k) database K151423
Recalls
-
- Terminated Z-2343-2018
There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.
Timeline
- Cleared FDA 510(k) K151423
- Recall initiated FDA recalls Z-2343-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LHI
- FDA applicant
- B.Braun Medical, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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