FDA Product Code FIP: Subsystem, Water Purification
FDA product code FIP covers water purification subsystems used in hemodialysis.
These systems process tap water through reverse osmosis, deionization, and other purification steps to produce water meeting strict AAMI standards for hemodialysis fluid preparation. Ultrapure water is critical to preventing dialysis-related complications caused by endotoxins and contaminants.
FIP devices are Class II medical devices, regulated under 21 CFR 876.5665 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Fresenius Medical Care Renal Therapies Group, LLC, Baxter Healthcare Corporation and B.Braun Medical, Inc..
FDA 510(k) Cleared Subsystem, Water Purification Devices (Product Code FIP)
About Product Code FIP - Regulatory Context
510(k) Submission Activity
117 total 510(k) submissions under product code FIP since 1977, with 117 receiving FDA clearance (average review time: 225 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FIP have taken an average of 147 days to reach a decision - down from 229 days historically, suggesting improved FDA processing for this classification.
FIP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →