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Safeport Manifold (Tm) (or Stopcock)

by Elcam Medical ACAL 510(k)

Active United States

510(k) K111016

Regulatory status

as of 27 Oct 2026

Recall ongoing. 12 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK111016 Date9 Jun 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

12 recalls · 12 ongoing · FDA

  • 11 recalls, same reason

    • Ongoing Z-0635-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0637-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0629-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0665-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0696-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0656-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0699-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0695-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0631-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0693-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0664-2026 FDA Class II initiated 29 Oct 2025

    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

    • Ongoing Z-3144-2024 FDA Class II initiated 8 Aug 2024

    Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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