# K031861: MIX2VIAL Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Jul 29, 2003 after 43 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.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062482: Vented Vial Adapter Transfer Device (2006), 4 descendants of its own
- K183187: nextaro Transfer System, nextaro va (2019), 2 descendants of its own
- K160503: Vented Vial Adapter Transfer Device - 13mm (2016), 2 descendants of its own
- K241976: nextaro® va, 15mm, 5µm (2024), 0 descendants of its own
- K240748: nextaro® v, 20/20 (2024), 0 descendants of its own

## Indications for use
The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.

Source page: https://510kreport.com/device/K031861
Methodology: https://510kreport.com/methodology