# K963583: Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Oct 7, 1996 after 31 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.
19 later devices descend from it; 6 cite it directly.
0 of 20 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
- K171796: Vial Adapter 15mm (2017), 6 descendants of its own
- K062482: Vented Vial Adapter Transfer Device (2006), 4 descendants of its own
- K041691: Clip 'N'ject Reconstitution System (Clip 'N'ject (2004), 3 descendants of its own
- K222718: Vial Adapter (2023), 2 descendants of its own
- K160503: Vented Vial Adapter Transfer Device - 13mm (2016), 2 descendants of its own

Source page: https://510kreport.com/device/K963583
Methodology: https://510kreport.com/methodology