# K071400: Smartsite Stopcock

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Dec 14, 2007 after 207 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock, Elcam Medical Acal (2006) Summary page 2.
- K960280: Ivac Needle Free Valve Administration Sets, Y (1996) Summary page 2.

## Indications for use
The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.

Source page: https://510kreport.com/device/K071400
Methodology: https://510kreport.com/methodology