FDA Product Code LHI: Set, I.v. Fluid Transfer
Under FDA product code LHI, IV fluid transfer sets are cleared for the transfer of sterile fluids between containers.
These sterile, closed-system tubing sets enable aseptic transfer of intravenous solutions from bulk containers to IV bags or bottles without exposing the fluid to the environment. They are used in pharmacy compounding and clinical preparation of IV admixtures.
LHI devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Jiangsu Caina Medical Co.,Ltd, Care Fusion and Icu Medical, Inc..
List of Set, I.v. Fluid Transfer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Set, I.v. Fluid Transfer devices (product code LHI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →