Yukon Medical, LLC - FDA 510(k) Cleared Devices

Yukon Medical, LLC is a developer of pharmaceutical preparation and drug delivery devices headquartered in Durham, North Carolina. Founded in 2008, the company designs innovative solutions for safe medication preparation and administration in clinical settings.

Yukon Medical has received 8 FDA 510(k) clearances from 8 total submissions since 2012. All submissions focus on General Hospital devices. The company's latest clearance was in 2025, demonstrating continued regulatory activity and product innovation.

The company specializes in vial access devices and closed system transfer devices. Key product lines include the Arisure® Closed System Transfer Device for hazardous drug protection and the Vialok® vented and non-vented vial access devices. These products support needle-free medication preparation with patented locking features and pressure-neutralizing filtration.

Yukon Medical is ISO 13485 certified and partners with leading medtech and pharmaceutical companies globally. Explore the company's complete FDA 510(k) clearance history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.