FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)

The FX CorAL 40 and 50 dialyzers are high-flux, single-use hemodialyzers designed for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease. They use semipermeable hollow fiber membranes to remove waste and excess fluid from blood during dialysis treatment, and are approved for use in both adult and pediatric patients.

The FX CorAL 40 and 50 dialyzers are substantially equivalent to predicate devices in intended use, principle of operation, design characteristics, sterilization method (steam sterilized), materials (polysulfone-polyvinylpyrrolidone fiber blend with vitamin E, polypropylene housing, polyurethane potting resin, and silicone seals), and performance requirements. The key difference is smaller surface areas (0.6 m² and 1.0 m² respectively) compared to larger predicate models.

Performance testing was conducted per ISO 8637-1 First Edition 2017-11 and FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers (August 1998). Biocompatibility testing included ISO standards for subchronic toxicity, bacterial reverse mutation assay, and in vitro mouse lymphoma gene mutation assay.

The FX CorAL 40 and 50 dialyzers are substantially equivalent to the predicate FX CorAL 60, 80, 100, 120, 600, 800, and 1000 dialyzers (K220721) because they share identical materials, design principles, sterilization method, and performance characteristics, differing only in smaller surface areas intended for pediatric use. All performance testing met predetermined acceptance criteria, biocompatibility was evaluated for the smaller surface areas with identical materials, and retrospective clinical data from 14 pediatric patients demonstrated adequate clearance and tolerability.