FX CorAL 40; FX CorAL 50

The FX CorAL 40 and 50 dialyzers are high-flux, single-use hemodialyzers designed for extracorporeal blood purification in patients with renal insufficiency. They remove uremic toxins, excess water, and correct blood electrolytes and acid-base balance using semipermeable hollow fiber membranes during hemodialysis, hemodiafiltration, or isolated ultrafiltration, including for pediatric patients.

The FX CorAL dialyzers are high-flux, steam-sterilized devices with polysulfone-polyvinylpyrrolidone fiber membranes containing vitamin E, polypropylene housing, and polyurethane potting resin. They operate via counter-current flow of blood and dialysate across semipermeable membranes for diffusion and ultrafiltration. The two models offer surface areas of 0.6 m² (FX CorAL 40) and 1.0 m² (FX CorAL 50) with typical urea clearances of 178 and 192-257 mL/min respectively.

The device is classified according to FDA guidance Use of International Standard ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, dated 08 September 2023). Human factors validation was conducted per FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

The FX CorAL 40 and 50 dialyzers are substantially equivalent to their predicate devices (FX CorAL 40 and 50 cleared under K242053, and secondary predicates FX CorAL 60, 80, 100, 120, 600, 800, and 1000 under K243874) because they are identical in manufacturing, design, sterilization method, materials, intended use, indications for use, principle of operation, design configuration, technological characteristics, and performance requirements. The proposed labeling changes do not impact device performance, biological safety, or usability.