# K122265: Vialok Single Vial Access Device Vented

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical, LLC
- Decided: Aug 14, 2012 after 15 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 K925401 (1993). 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)
- K121182: Vialok Non-Vented, Yukon Medical, LLC (2012) Summary page 2.
- K062482: Vented Vial Adapter Transfer Device, Medimop Medical Projects, Ltd. (2006) Summary page 2.

## Indications for use
The Vented Single Vial Access Device is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies. The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

Source page: https://510kreport.com/device/K122265
Methodology: https://510kreport.com/methodology