# K061143: Robertsite Stopcock

- Pathway: 510(k) (Traditional)
- Applicant: Halkey-Roberts Corp.
- Decided: May 10, 2006 after 15 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 K901063 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955782: Med-Net Stopcocks, Mednet, Inc. (1996) Summary page 1.
- K002689: Swabsite Swabbable Valve, Model 245000, Quest Medical, Inc. (2001) Summary page 1.
- K040634: Robertsite Vial Adapter, Model 245700021, Halkey-Roberts Corp. (2004) Summary page 1.

## Indications for use
The Robertsite@ stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.

Source page: https://510kreport.com/device/K061143
Methodology: https://510kreport.com/methodology