# K944320: Vented/Non-Vented Gemini Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Feb 14, 1995 after 169 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.
5 later devices descend from it; 5 cite it directly.
0 of 6 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
- K955821: I.V. Administration Sets (1996), 1 descendant of its own
- K971500: Access Systems Needleless Vial Adapter (1997), 0 descendants of its own
- K962801: Safe Mate I.V. Extension Sets (1996), 0 descendants of its own
- K962802: Safe Mate I.V. Fluid Delivery Sets (1996), 0 descendants of its own
- K961327: Bec Needleless Injection Site (1996), 0 descendants of its own

## Recalls of this device
- Aug 2, 2021 · Class II · Z-2459-2021: 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 
- Feb 15, 2016 · Class II · Z-1179-2016: CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.
- Nov 5, 2015 · Class II · Z-0445-2016: CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
- Jun 17, 2014 · Class II · Z-2025-2014: CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip
- Nov 8, 2013 · Class II · Z-0435-2014: CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
- Nov 8, 2013 · Class II · Z-0450-2014: CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.
- Aug 30, 2013 · Class II · Z-2285-2013: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

Source page: https://510kreport.com/device/K944320
Methodology: https://510kreport.com/methodology