# K072511: Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM

- Pathway: 510(k) (Abbreviated)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Dec 13, 2007 after 98 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
Longest line of descent: 3 generations back to K790472 (1979). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K052790: Smartsite Vented Vial  Access Device, Model TBD, Cardinal Health, Alaris Products (2005) Summary page 1.

## Indications for use
The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial

Source page: https://510kreport.com/device/K072511
Methodology: https://510kreport.com/methodology