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510(k) K201422

Arisure Closed System Drug Transfer Device (CSTD) by Yukon Medical, LLC — Product Code ONB

K201422 is an FDA 510(k) premarket notification submitted by Yukon Medical, LLC for the device "Arisure Closed System Drug Transfer Device (CSTD)". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System), a Class II device regulated under 21 CFR 880.5440. Yukon Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2021
Date Received
May 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

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)
  • K172884 — Arisure Closed Vial Adapter (October 3, 2017)
  • K172631 — Arisure Dry Spike (September 29, 2017)
  • K171101 — Closed Male Luer (June 2, 2017)
  • K151963 — SmartSite Vented Vial Access Device (July 31, 2015)
  • 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 ONB

  • K251722 — ProSeal™ Transfer Injector (421120, 421130, 421140) (December 5, 2025)
  • K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (October 21, 2025)
  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251411 — Chemfort Female Luer Lock Adaptor (August 5, 2025)
  • K251340 — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (May 29, 2025)
  • K243976 — ZeroClear™ Bag Access (423100) (January 22, 2025)
  • K240517 — ProSeal™ Vented Universal Vial Adaptor (December 26, 2024)
  • K241988 — ProSeal™ Closed System Bag Access (October 23, 2024)
  • K241735 — ProSeal™ In Line Pump Set (423850) (October 10, 2024)
  • K241823 — ToxiSeal™ Vial Adaptor (August 30, 2024)

FDA data resources