# K151963: SmartSite Vented Vial Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical, LLC
- Decided: Jul 31, 2015 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 K901063 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052790: Smartsite Vented Vial  Access Device, Model TBD, Cardinal Health, Alaris Products (2005) Summary page 5.

## Most influential descendants
- K243486: SmartSiteTM Vented Vial Access Device (2024), 0 descendants of its own

## Indications for use
The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with standard rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Source page: https://510kreport.com/device/K151963
Methodology: https://510kreport.com/methodology