# K061285: Smartsite Needle Free Valve Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Jul 26, 2006 after 79 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960280 (1996). 1 ancestor in all.
6 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960280: Ivac Needle Free Valve Administration Sets, Y (1996) Summary page 1.

## Most influential descendants
- K103562: Centurion Pressure Injectable Extension Set (2011), 1 descendant of its own
- K090134: Intravenous Power Injector Extension Set (2009), 1 descendant of its own
- K223088: BD SmartSite™ Needle-Free Connector (2023), 0 descendants of its own
- K141285: Busse Extension Set (2015), 0 descendants of its own
- K100576: High Pressure Sets-400 Psi (2010), 0 descendants of its own

## Recalls of this device
- Aug 2, 2021 · Class II · Z-2454-2021: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy 
- Aug 2, 2021 · Class II · Z-2455-2021: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy 

## Indications for use
The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.

Source page: https://510kreport.com/device/K061285
Methodology: https://510kreport.com/methodology