# K931550: EZ Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Y
- Decided: Jan 10, 1994 after 287 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032147: Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series (2003), 1 descendant of its own
- K063288: Signature Edition Gold Infusion System, Model 7X3X (2006), 0 descendants of its own

## Recalls of this device
- Aug 2, 2021 · Class II · Z-2465-2021: 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 30, 2013 · Class II · Z-2279-2013: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (

Source page: https://510kreport.com/device/K931550
Methodology: https://510kreport.com/methodology