# K960280: Ivac Needle Free Valve Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Y
- Decided: Apr 4, 1996 after 76 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ICU Medical, Inc. Clave Connector: named in the summary without a submission number

## Most influential descendants
- K970485: Smartsite Access Pin (1997), 11 descendants of its own
- K061285: Smartsite Needle Free Valve Administration Sets (2006), 6 descendants of its own
- K052790: Smartsite Vented Vial  Access Device, Model TBD (2005), 5 descendants of its own
- K002689: Swabsite Swabbable Valve, Model 245000 (2001), 3 descendants of its own
- K151963: SmartSite Vented Vial Access Device (2015), 1 descendant of its own

## Recalls of this device
- Aug 2, 2021 · Class II · Z-2460-2021: 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-2466-2021: 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-2467-2021: 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 
- Oct 9, 2015 · Class II · Z-0221-2016: CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
- Jan 13, 2015 · Class II · Z-1053-2015: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
- Mar 19, 2014 · Class II · Z-1459-2014: Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
- Jan 22, 2014 · Class II · Z-0925-2014: CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, m

## Indications for use
The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.

Source page: https://510kreport.com/device/K960280
Methodology: https://510kreport.com/methodology