Identifiers
- 510(k) Number
- K122343 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 Pureflux-H Hemodialyzer is a high-permeability dialyzer designed as an artificial kidney. It facilitates the removal of toxins and excess fluids from the blood of patients with renal failure by utilizing a polyethersulfone fiber membrane. Blood and dialysate flow countercurrent through separate compartments, enabling efficient transfer of waste products and fluids across the membrane.
This device is intended for use in clinical settings, such as hospitals or dialysis centers. It is supplied as a single-use medical device and requires regulatory compliance under FDA 510(k) clearance (K122343). The Pureflux-H Hemodialyzer adheres to classification under regulation 876.5860 as a high-permeability dialyzer, with or without a sealed dialysate system, and is intended for renal replacement therapy. No specific MRI safety or reusable design information is provided.
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: PUREFLUX-H HEMODIALYZER (K122343) — FDA 510 (k) | Innolitics, PUREFLUX-H HEMODIALYZER 510 (k) K122343 - FDA.report, PUREFLUX-H HEMODIALYZER (K122343) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122343 | Class II | Active |
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Manufacturer
- Manufacturer
- Nipro Medical Corporation
Sources (1)
- FDA 510(k) K122343 24 fields · synced Sep 19, 2026