# K230464: MixJect® Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: West Pharma. Services IL, Ltd.
- Decided: May 22, 2023 after 90 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
Longest line of descent: 1 generation back to K001293 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001293: Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle, Medimop Medical Projects, Ltd. (2000) Summary page 5.

## Indications for use
The device is intended for the transfer and injection of drugs contained in a vial.

Source page: https://510kreport.com/device/K230464
Methodology: https://510kreport.com/methodology