# K140730: VIAL2BAG Direct Connect

- Pathway: 510(k) (Traditional)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Jun 12, 2014 after 80 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K883614 (1988). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072759: VIAL2BAG, Medimop Medical Projects, Ltd. (2007) Summary page 2.
- 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 2.

## Most influential descendants
- K170095: Vial2Bag Direct Connect (2017), 0 descendants of its own

## Recalls of this device
- Oct 6, 2017 · Class II · Z-0972-2018: Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.

## Indications for use
The Vial2BagTM Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

Source page: https://510kreport.com/device/K140730
Methodology: https://510kreport.com/methodology