# K172884: Arisure Closed Vial Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical
- Decided: Oct 3, 2017 after 12 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)
- K132863: Smartsite Vialshield, Yukon Medical, LLC (2013) Summary page 5.

## Indications for use
The Arisure™ Closed Vial Adapter 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 Arisure™ Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Source page: https://510kreport.com/device/K172884
Methodology: https://510kreport.com/methodology