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Elisio™-H

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260533

by Nipro Medical Corporation

Identifiers

510(k) Number
K260533 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 Dialyzer is a high-permeability hemodialysis device designed for blood purification in renal replacement therapy. It employs synthetic hollow fiber membranes to efficiently remove waste products, excess fluids, and electrolytes from the blood of patients with end-stage renal disease or acute kidney injury. The device operates within a sealed dialysate system, ensuring sterile and controlled hemodialysis sessions.

This dialyzer is supplied as a single-use, sterile device intended for use in hemodialysis centers and hospital settings. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The device is available in a surface area of 1.1 square meters, with a maximum transmembrane pressure rating of 66 kPa (500 mmHg). Storage and handling must comply with manufacturer guidelines to maintain sterility and performance integrity.

Frequently asked questions

What is the Elisio-H Dialyzer specifically designed to do in a clinical setting?

The Elisio-H Dialyzer is designed for blood purification during hemodialysis, specifically to remove waste products, excess fluids, and electrolytes from the blood of patients suffering from end-stage renal disease or acute kidney injury. Its high-permeability synthetic hollow fiber membranes enable efficient filtration within a sealed dialysate system, ensuring controlled and sterile dialysis sessions.

Is the Elisio-H Dialyzer intended for single-use or repeated use, and how should it be stored?

The Elisio-H Dialyzer is a single-use device, meaning it is not meant for reuse. To maintain sterility and performance, storage and handling must strictly follow the manufacturer’s guidelines, which are provided to ensure the device remains intact and functional until use.

What surface area does the Elisio-H Dialyzer have, and what does this mean for its performance?

The Elisio-H Dialyzer has a surface area of 1.1 square meters, which refers to the total membrane area available for blood filtration. This larger surface area generally enhances efficiency by increasing the contact between blood and the dialyzer membrane, allowing for more effective removal of waste and excess fluids during hemodialysis.

What regulatory pathway did the Elisio-H Dialyzer follow to gain market authorization in the U.S.?

The Elisio-H Dialyzer received FDA clearance through the 510(k) pathway, which demonstrates that it is substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with FDA regulations as a Class II medical device, ensuring it meets safety and performance standards for use in hemodialysis.

What is the maximum transmembrane pressure rating for the Elisio-H Dialyzer, and why is this important?

The Elisio-H Dialyzer has a maximum transmembrane pressure rating of 66 kPa (500 mmHg). This rating indicates the highest pressure difference the device can safely handle during operation, preventing membrane damage or leakage. Adhering to this limit ensures reliable performance and patient safety during hemodialysis sessions.

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. Sources consulted: Renal Products | Medical Device Business - NIPRO CORPORATION, ELISIO™-H (K260533) — FDA 510(k) | Innolitics, NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-11H Surface… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (1)

  • FDA 510(k) K260533 24 fields · synced Sep 20, 2026