Elisio-H and Elisio-M Hemodialyzers
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122347 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 and Elisio-M are high-permeability hemodialyzers designed for blood purification during renal replacement therapy. These devices facilitate the removal of solutes, toxins, and excess fluids from the bloodstream, supporting patients with acute or chronic kidney disease by maintaining metabolic balance and electrolyte homeostasis.
Supplied as single-use, sterile devices, the Elisio-H and Elisio-M are intended for use in hemodialysis treatment settings. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Regulation (MDR) in the EU. Each hemodialyzer is available in specific model variants (H and M) and must be stored under manufacturer-recommended conditions to ensure sterility and performance integrity.
Frequently asked questions
What clinical conditions are the Elisio-H and Elisio-M hemodialyzers primarily designed to support in patients?
The Elisio-H and Elisio-M hemodialyzers are specifically designed for blood purification during renal replacement therapy, helping to manage patients with acute or chronic kidney disease. They facilitate the removal of solutes, toxins, and excess fluids to maintain metabolic balance and electrolyte homeostasis, which is critical for patients undergoing dialysis.
Are the Elisio-H and Elisio-M hemodialyzers reusable, or are they intended for single-use only?
The Elisio-H and Elisio-M hemodialyzers are supplied as single-use, sterile devices. This design ensures patient safety and sterility integrity, as reuse could compromise the device’s performance and introduce contamination risks.
What storage conditions are recommended to maintain the sterility and performance of these hemodialyzers?
The manufacturer recommends storing the Elisio-H and Elisio-M hemodialyzers under specific conditions to preserve sterility and performance. While exact details are not provided in the data, standard practice for single-use hemodialyzers typically involves keeping them in a sealed, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathways have the Elisio-H and Elisio-M hemodialyzers undergone, and what does this imply for their use?
The Elisio-H and Elisio-M hemodialyzers have undergone FDA 510(k) clearance and comply with the EU’s Medical Device Regulation (MDR). The FDA classification as a Class II device indicates they are subject to special controls to ensure safety and effectiveness, while MDR compliance ensures they meet EU standards for medical devices. This implies they are approved for use in both the U.S. and EU markets under these regulatory frameworks.
Are there different model variants available for the Elisio-H and Elisio-M hemodialyzers, and if so, what distinguishes them?
Yes, the Elisio-H and Elisio-M hemodialyzers are available in two distinct model variants: Elisio-H and Elisio-M. While the exact technical differences between the two are not detailed in the provided data, the naming convention suggests they may differ in specifications such as membrane permeability, surface area, or intended patient populations (e.g., pediatric vs. adult). These distinctions are typically tailored to optimize dialysis efficiency for specific patient needs.
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 | K122347 | Class II | Active |
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Manufacturer
- Manufacturer
- Nipro Medical Corporation
Sources (2)
- FDA 510(k) K122347 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026