# K960512: Gemini PC-Itx

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Nov 21, 1996 after 290 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- 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.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PC-1: named in the summary without a submission number
- (no number) PC-2TX: named in the summary without a submission number
- (no number) PC-4: named in the summary without a submission number

## Indications for use
The Gemini family of infusion devices are intended for intravascular administration of fluids, medications, blood, and blood products into a patient in a controlled manner.

Source page: https://510kreport.com/device/K960512
Methodology: https://510kreport.com/methodology