Identifiers
- 510(k) Number
- K161304 FDA 510(k)
- FDA Product Code
- FIP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5665 FDA 510(k)
- Regulation Number
- 876.5665 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EndoPur Filter is a water purification subsystem designed to provide high-flow filtration for the production of dialysis-quality water. It functions by providing 5-log endotoxin retention when installed following other water treatment equipment, such as reverse osmosis systems.
This device is intended for application within centralized water systems and water rooms. It is an FDA 510(k)-cleared Class II medical device.
Frequently asked questions
What is the primary function of the EndoPur Filter?
The EndoPur Filter is a water purification subsystem designed to provide high-flow filtration for the production of dialysis-quality water. It achieves this by providing 5-log endotoxin retention.
Where should the EndoPur Filter be installed in a water system?
The device is intended for installation within centralized water systems and water rooms. It is designed to be installed following other water treatment equipment, such as reverse osmosis systems, to ensure effective filtration.
What is the regulatory status of the EndoPur Filter?
The EndoPur Filter is an FDA 510(k)-cleared Class II medical device. It was cleared under the K161304 submission, which determined the device to be substantially equivalent to existing systems.
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: EndoPur® Endotoxin Filter Flat | Nephros, PDF Nephros EndoPur Endotoxin Filters information, Nephros 70-0120H EndoPur 20-Inch Ultrafilter - 222 O-Ring, Dialysis Water
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161304 | Class II | Active |
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Manufacturer
- Manufacturer
- Nephros, Inc.
Sources (1)
- FDA 510(k) K161304 24 fields · synced Sep 22, 2026