# K121182: Vialok Non-Vented

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical, LLC
- Decided: May 3, 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: 2 generations back to K790472 (1979). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013087: Single Dose Dispensing Pin, Model 2201, Alaris Medical Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K122265: Vialok Single Vial Access Device Vented (2012), 0 descendants of its own

## Indications for use
The ViaLokTM 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 ViaLokTM 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/K121182
Methodology: https://510kreport.com/methodology