Home / 510(k) Clearances / K192154

510(k) K192154

Rio Vial-to-Bag Drug Reconstitution Device by Icu Medical — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2020
Date Received
August 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Icu Medical

  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242117 — LifeShield Infusion Safety Software Suite (April 2, 2025)
  • K242115 — Plum Duo™ Precision IV Pump (April 2, 2025)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K223606 — LifeShield™ Infusion Safety Software Suite (August 24, 2023)
  • K223607 — Plum Duo™ Infusion System (August 24, 2023)
  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K190157 — Diana ChemoClave Transfer Set (October 23, 2019)

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)