# K243486: SmartSiteTM Vented Vial Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical, LLC
- Decided: Dec 6, 2024 after 28 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: 4 generations back to K901063 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151963: SmartSite Vented Vial Access Device, Yukon Medical, LLC (2015) Summary page 6.

## Indications for use
The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

Source page: https://510kreport.com/device/K243486
Methodology: https://510kreport.com/methodology