FDA Product Code FPA: Set, Administration, Intravascular
Intravenous administration sets are among the most fundamental devices in hospital care. FDA product code FPA covers intravascular administration sets used to deliver fluids, medications, and blood products.
These sets consist of tubing, drip chambers, flow regulators, and connectors that link IV bags or bottles to the patient's vascular access device. They are used across virtually every clinical setting, from emergency departments to intensive care units.
FPA devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Baxter Healthcare Corporation, B.Braun Medical, Inc. and Quest Medical, Inc..
FDA 510(k) Cleared Set, Administration, Intravascular Devices (Product Code FPA)
About Product Code FPA - Regulatory Context
510(k) Submission Activity
1174 total 510(k) submissions under product code FPA since 1976, with 1174 receiving FDA clearance (average review time: 117 days).
Submission volume has declined in recent years - 15 submissions in the last 24 months compared to 28 in the prior period.
FDA Review Time
Recent submissions under FPA have taken an average of 190 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.
FPA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →