# K111016: Safeport Manifold (TM) (or Stopcock)

- Pathway: 510(k) (Special)
- Applicant: Elcam Medical Acal
- Decided: Jun 9, 2011 after 58 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862691 (1986). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032393: Induction and Sampling Manifold (or Stopcock), Elcam Medical Acal (2003) Summary page 1.

## Most influential descendants
- K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold (2013), 1 descendant of its own
- K242255: Qitexio® 4-Way Stopcock (QIT014) (2025), 0 descendants of its own
- K210516: Clicky Cross (2022), 0 descendants of its own
- K172266: Dynarex Three-Way Stopcock (2018), 0 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0629-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0631-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0637-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0664-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0665-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0693-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0695-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0699-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0635-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0656-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0696-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Aug 8, 2024 · Class II · Z-3144-2024: 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.

## Indications for use
Safeport Manifold is indicated to serve as a flow control and a conduit device for ILV fluids delivery to the patient's vascular system. The product is intended for delivering 1.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation

Source page: https://510kreport.com/device/K111016
Methodology: https://510kreport.com/methodology