| K-number | K260533 |
| Device name | ELISIO-H |
| Applicant | Nipro Medical Corporation |
| Product code | KDI |
| Device class | Class II |
| Decision date | Mar 19, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.5860 |
The ELISIO™-H is a single-use, high-flux hemodialyzer designed for extracorporeal blood purification in patients with acute or chronic kidney disease. It removes uremic toxins, excess fluid, and electrolytes through diffusion and/or convection, supporting hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration modalities.
The device features a plastic cylindrical housing with separate blood and dialysate compartments divided by a polyethersulfone (POLYNEPHRON™) semi-permeable membrane. It is available in eight surface areas (0.9–2.5 m²), sterilized by gamma radiation, has a three-year shelf life, and uses polypropylene housing free of BPA and DEHP. The design, materials, manufacturing, and performance specifications are identical to the cleared ELISIO™-H predecessors.
Performance testing followed ISO 8637-1:2024 (Extracorporeal systems for blood purification) and FDA Guidance for High Permeability Hemodialyzers. Testing included mechanical integrity, solute clearance (urea, creatinine, phosphate, vitamin B12, sieving coefficients, albumin, inulin, β2-microglobulin), ultrafiltration rate, endotoxin transfer (ANSI/AAMI ST72), and shelf-life validation (ASTM F1980).
The ELISIO™-H is substantially equivalent because it is identical in design, materials, manufacturing, sterilization, shelf life, and performance specifications to the predicate ELISIO™-H (K131935, K140191), with expanded indications (HDF, HF, ISO-UF) matching the secondary predicate Optiflux (K203062). Performance testing confirms comparable solute clearance, membrane selectivity, and high-flux permeability with no excessive protein loss.
View the full FDA submission: accessdata.fda.gov