# K970485: Smartsite Access Pin

- Pathway: 510(k) (Traditional)
- Applicant: Ivac Medical Systems
- Decided: Apr 21, 1997 after 70 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901063 (1990). 3 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 15 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.
- K910546: Piggy Lock Needle Housing, Icu Medical, Inc. (1991) Summary page 1.
- K901063: Luer Lock Transfer Pin, Acacia, Inc. (1990) Summary page 1.

## Most influential descendants
- 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
- K132863: Smartsite Vialshield (2013), 1 descendant of its own
- K243486: SmartSiteTM Vented Vial Access Device (2024), 0 descendants of its own

## Recalls of this device
- Aug 2, 2021 · Class II · Z-2461-2021: 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-2468-2021: 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 
- Nov 17, 2016 · Class II · Z-1883-2017: CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusi

## Indications for use
The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.

Source page: https://510kreport.com/device/K970485
Methodology: https://510kreport.com/methodology