Multi-Port Manifold
510(k) K932512
Multi-Port Manifold is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K932512 on 22 Feb 1994, active as of 22 Oct 2026. 3 FDA recalls are linked to it.
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 | NumberK932512 | Date22 Feb 1994 | StatusActive |
Official records
- FDA 510(k) database K932512
Recalls
-
- Terminated Z-0478-2012
- Terminated Z-0476-2012
- Terminated Z-0477-2012
During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.
Timeline
- Cleared FDA 510(k) K932512
- Recall initiated FDA recalls Z-0478-2012
- Recall initiated FDA recalls Z-0476-2012
- Recall initiated FDA recalls Z-0477-2012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMG
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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