# K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock

- Pathway: 510(k) (Special)
- Applicant: Elcam Medical Acal
- Decided: Apr 13, 2006 after 73 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862691 (1986). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022895: Elcam Stopcocks and Manifolds, Medical Device Consultants, Inc. (2002) Summary page 1.

## Most influential descendants
- K211204: SafePort (TM) Manifold (or Stopcock) (2022), 0 descendants of its own
- K103165: Blood Sampling Set (2010), 0 descendants of its own
- K082106: Elcam Antimicrobial Closed Stopcocks (DSS and TSS) (2008), 0 descendants of its own
- K071400: Smartsite Stopcock (2007), 0 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0606-2026: 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-0608-2026: 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-0649-2026: 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-0650-2026: 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-0607-2026: 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-0645-2026: 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-0646-2026: 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-0647-2026: 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-0648-2026: 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-0651-2026: 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-0708-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Nov 20, 2019 · Class II · Z-0939-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 20, 2019 · Class II · Z-0937-2020: Potential for leakage at the joint between the blood filters and tubing
- Feb 2, 2017 · Class II · Z-1869-2017: The stopcock was found to have punctures.
- Jan 8, 2014 · Class II · Z-0987-2014: Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle fre
- Mar 27, 2009 · Not classified · Z-1432-2009: Device defect is occlusion/no flow.
- Jun 11, 2008 · Not classified · Z-2205-2008: Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
- Jun 11, 2008 · Not classified · Z-2207-2008: Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
- Jun 11, 2008 · Not classified · Z-2206-2008: Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
- Jun 11, 2008 · Not classified · Z-2208-2008: Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

## Indications for use
Elcam Closed Swabable Stopcock and MRVLS is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion

Source page: https://510kreport.com/device/K060231
Methodology: https://510kreport.com/methodology