Identifiers
- 510(k) Number
- K131381 FDA 510(k)
- FDA Product Code
- KDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elisio-H Hemodialyzer is a high-permeability dialyzer designed for hemodialysis treatment. It facilitates the removal of waste products, excess fluids, and electrolytes from the blood of patients with renal failure by diffusion and convection through a semipermeable membrane.
This single-use, sterile device is intended for use in clinical settings with hemodialysis machines. It is classified as a Class II medical device under FDA regulations (21 CFR 876.5860) and has received FDA 510(k) clearance and EU MDR authorization. Multiple reference codes are associated with its regulatory submissions, ensuring compliance with international standards for hemodialysis equipment.
Frequently asked questions
What is the Elisio-H Hemodialyzer primarily used for in clinical settings?
The Elisio-H Hemodialyzer is designed specifically for hemodialysis treatment, which removes waste products, excess fluids, and electrolytes from the blood of patients suffering from renal failure. It achieves this through diffusion and convection processes across its semipermeable membrane, making it suitable for patients requiring regular dialysis sessions.
Is the Elisio-H Hemodialyzer intended for single-use or can it be reused?
The Elisio-H Hemodialyzer is explicitly described as a single-use device, meaning it is intended for one-time use in a clinical setting before disposal. Reuse is not recommended or supported by the manufacturer.
How is the Elisio-H Hemodialyzer supplied, and is it sterile?
The Elisio-H Hemodialyzer is supplied as a sterile, single-use device, packaged for direct use in hemodialysis machines. Sterility ensures safe, contamination-free use in clinical environments where patient safety is critical.
What regulatory pathways has the Elisio-H Hemodialyzer followed for approval?
The Elisio-H Hemodialyzer has received FDA 510(k) clearance and EU MDR authorization, confirming compliance with both U.S. and European regulatory standards. It is classified as a Class II medical device under FDA regulations (21 CFR 876.5860), with multiple reference codes associated with its submissions.
Are there different sizes or models of the Elisio-H Hemodialyzer, or is it available in a single configuration?
The provided data does not specify distinct sizes or models of the Elisio-H Hemodialyzer, so it appears to be offered in a single configuration designed for high-permeability hemodialysis. For exact specifications, consulting the manufacturer’s technical documentation would be necessary.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131381 | Class II | Active |
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Manufacturer
- Manufacturer
- Nipro Medical Corporation
Sources (2)
- FDA 510(k) K131381 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026