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 Ameriwater, Mar Cor Purification, Inc. and Fresenius Medical Care Renal Therapies Group, LLC.