FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)

The FX CorAL dialyzers are high-flux, single-use hemodialyzers with seven configurations (60, 80, 100, 120, 600, 800, 1000) designed for acute and chronic hemodialysis. They remove uremic toxins, excess water, and correct blood electrolytes and acid-base balance by passing blood through semipermeable hollow fiber membranes in counter-current flow with dialysate.

The proposed FX CorAL dialyzers are identical to the predicate FX CorAL dialyzers (K220721) in intended use, principle of operation, design and configuration, technological characteristics, materials (polysulfone-polyvinylpyrrolidone blend fiber bundle, polypropylene housing, polyurethane potting resin), and performance requirements. Urea clearance ranges from 270–292 mL/min depending on model and flow conditions.

FDA guidance documents cited: Use of International Standard ISO 10993-1 (Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process, 08 September 2023) and Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016). No electrical safety, software, animal, or clinical studies were performed.

Substantial equivalence is established because the proposed dialyzers are physically and functionally identical to the predicate device across all material and design parameters, sterilization method is unchanged, and labeling changes do not impact performance or biological safety. Since the proposed dialyzers share identical manufacturing, design, materials, and performance characteristics with the predicate K220721 submission, performance and biocompatibility data from the predicate remain fully applicable, satisfying the SE standard.