# K001293: Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle

- Pathway: 510(k) (Special)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: May 5, 2000 after 11 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.
13 later devices descend from it; 7 cite it directly.
1 of 14 devices in its family (counting itself) has 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
- K062482: Vented Vial Adapter Transfer Device (2006), 4 descendants of its own
- K160503: Vented Vial Adapter Transfer Device - 13mm (2016), 2 descendants of its own
- K140730: VIAL2BAG Direct Connect (2014), 1 descendant of its own
- K122023: Mixject with Spray Head (2012), 1 descendant of its own
- K232875: Vial Adapter 20mm (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K001293
Methodology: https://510kreport.com/methodology