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 Hangzhou Qiantang Longyue Biotechnology Co., Ltd., Sfm Medical Devices GmbH and Yukon Medical, LLC.
FDA 510(k) Cleared Set, I.v. Fluid Transfer Devices (Product Code LHI)
About Product Code LHI - Regulatory Context
510(k) Submission Activity
205 total 510(k) submissions under product code LHI since 1981, with 205 receiving FDA clearance (average review time: 123 days).
Submission volume has declined in recent years - 10 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
Recent submissions under LHI have taken an average of 183 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.
LHI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →