# K894842: Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Sep 12, 1989 after 43 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- May 6, 2019 · Class I · Z-1770-2019: An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended deliver
- Apr 20, 2018 · Class II · Z-0385-2019: Complaints where users were unable to prime the administration set.

Source page: https://510kreport.com/device/K894842
Methodology: https://510kreport.com/methodology