# K072759: VIAL2BAG

- Pathway: 510(k) (Abbreviated)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Dec 13, 2007 after 76 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883614 (1988). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040634: Robertsite Vial Adapter, Model 245700021, Halkey-Roberts Corp. (2004) Summary page 1.
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro, Carmel Pharma Ab. (1998) Summary page 1.
- K051669: Tevadaptor Closed Drug Reconstitution and Transfer System, Migada Plant (2005) Summary page 1.

## Most influential descendants
- K140730: VIAL2BAG Direct Connect (2014), 1 descendant of its own
- K170095: Vial2Bag Direct Connect (2017), 0 descendants of its own

## Recalls of this device
- Dec 26, 2018 · Class I · Z-0768-2019: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag is recalled due to similarities with 13mm Vial2Bag DC.

## Indications for use
The Vial2Bag is indicated to serve as a connecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.

Source page: https://510kreport.com/device/K072759
Methodology: https://510kreport.com/methodology