FDA Product Code FRN: Pump, Infusion
Accurate drug delivery is critical to patient safety in every care setting. FDA product code FRN covers infusion pumps used for the controlled delivery of fluids and medications.
These devices deliver precise volumes of drugs, nutrients, or fluids at programmed rates via intravenous, subcutaneous, or enteral routes. They range from large-volume pumps for IV fluids to syringe drivers for concentrated analgesics and chemotherapy.
FRN devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Baxter Healthcare Corporation, Icu Medical, Inc. and Zevex, Inc..
FDA 510(k) Cleared Pump, Infusion Devices (Product Code FRN)
About Product Code FRN - Regulatory Context
510(k) Submission Activity
848 total 510(k) submissions under product code FRN since 1976, with 847 receiving FDA clearance (average review time: 126 days).
Submission volume has increased in recent years - 13 submissions in the last 24 months compared to 10 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FRN have taken an average of 145 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
FRN devices are reviewed by the General Hospital panel. Browse all General Hospital devices →