# K960466: Ivex-2 Extension Set with Y-Injection Site (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 29, 1996 after 148 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K964850: Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter (1997), 2 descendants of its own
- K153158: Solution Administration Sets with 0.2 Micron Filter (2015), 0 descendants of its own
- K994429: Venusa, LTD. Extension Set with Filter (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K960466
Methodology: https://510kreport.com/methodology