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510(k) K151963

SmartSite Vented Vial Access Device by Yukon Medical, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2015
Date Received
July 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Yukon Medical, LLC

  • K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) (March 21, 2025)
  • K243486 — SmartSiteTM Vented Vial Access Device (December 6, 2024)
  • K201422 — Arisure Closed System Drug Transfer Device (CSTD) (March 2, 2021)
  • K172884 — Arisure Closed Vial Adapter (October 3, 2017)
  • K172631 — Arisure Dry Spike (September 29, 2017)
  • K171101 — Closed Male Luer (June 2, 2017)
  • K132863 — SMARTSITE VIALSHIELD (October 4, 2013)
  • K122265 — VIALOK SINGLE VIAL ACCESS DEVICE VENTED (August 14, 2012)
  • K121182 — VIALOK NON-VENTED (May 3, 2012)
  • K120799 — ARISURE NEUTRAL VALVE (March 30, 2012)

Other clearances for product code LHI

  • K250345 — Medline Bag Decanter (October 24, 2025)
  • K251715 — FlowArt® Vial Access Device Vented (October 14, 2025)
  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K243404 — HyHub™ and HyHub™ Duo Vial Access Devices (July 18, 2025)
  • K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) (March 21, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K243486 — SmartSiteTM Vented Vial Access Device (December 6, 2024)
  • K241976 — nextaro® va, 15mm, 5µm (September 6, 2024)
  • K233287 — Vent Vial Adapter (July 26, 2024)
  • K232987 — FlowArt Valve for Vial Access (June 26, 2024)