# K170095: Vial2Bag Direct Connect

- Pathway: 510(k) (Special)
- Applicant: Medimop Medical Project, Ltd.
- Decided: Mar 8, 2017 after 56 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K883614 (1988). 13 ancestors in all.
No later device cites it as a predicate yet.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140730: VIAL2BAG Direct Connect, Medimop Medical Projects, Ltd. (2014) Summary page 4.

## Recalls of this device
- Dec 26, 2018 · Class I · Z-0767-2019: Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solu
- Dec 26, 2018 · Class I · Z-0769-2019: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.
- 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 Vial2Bag™ 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/K170095
Methodology: https://510kreport.com/methodology