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FDA 510(k)

SmartSiteTM Vented Vial Access Device

K-Number: K243486 · 2024-12-06

ApplicantYukon Medical, LLC
Decision Date2024-12-06
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SmartSiteTM Vented Vial Access Device is a medical device manufactured by Yukon Medical, LLC. It received FDA 510(k) clearance on 2024-12-06 under approval number K243486. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartSiteTM Vented Vial Access Device?

SmartSiteTM Vented Vial Access Device is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Yukon Medical, LLC. The 510(k) number is K243486.

When was SmartSiteTM Vented Vial Access Device approved by the FDA?

SmartSiteTM Vented Vial Access Device received FDA 510(k) clearance on 2024-12-06, under approval number K243486.

What company makes SmartSiteTM Vented Vial Access Device?

SmartSiteTM Vented Vial Access Device is manufactured by Yukon Medical, LLC.

What is the FDA product code for SmartSiteTM Vented Vial Access Device?

The FDA product code for SmartSiteTM Vented Vial Access Device is LHI.

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41613088 Orphan medical devices: addressing the regulatory and access gaps in the EU and US. Frontiers in public health (2025) PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026)

Other Devices by Yukon Medical, LLC

K201422Arisure Closed System Drug Transfer Device (CSTD) K240761Arisure® Closed Male Luer with Spike Adapter (YM060)

Related Devices (Code: LHI)

K161800OnSite-IVPharmc, LLC K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. K151423APEX Compounding System Transfer SetB.Braun Medical, Inc. K162216GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A. K171796Vial Adapter 15mmMedimop Medical Project , Ltd. K172884Arisure Closed Vial AdapterYukon Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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