Identifiers
- 510(k) Number
- K090885 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 DSU Dual Stage Ultrafilter is a water purification subsystem designed to remove bacteria, viruses, and endotoxins from water. Classified as a subsystem under FDA regulation 876.5665, it employs a two-stage filtration process to achieve high-purity water suitable for medical and clinical applications, including wound cleansing, surgical handwashing, and equipment cleaning. Its filtration capabilities align with standards for dialysis-quality water and microbiological safety, ensuring compliance with stringent medical requirements.
This device is supplied as a reusable or replaceable cartridge system, intended for point-of-use or inline application following other water treatment processes such as reverse osmosis. It is not sterile by design but achieves effective filtration through a 0.005-micron pore size, retaining contaminants for up to 180 days under specified conditions. The DSU Dual Stage Ultrafilter operates within FDA-regulated classifications and holds a 510(k) clearance (K090885) for substantial equivalence, with advisory committee oversight from Gastroenterology and Urology panels. Storage and handling follow manufacturer guidelines to maintain performance and regulatory compliance.
Frequently asked questions
What types of contaminants does the DSU Dual Stage Ultrafilter remove from water, and how does it achieve this?
The DSU Dual Stage Ultrafilter removes bacteria, viruses, and endotoxins from water through a two-stage filtration process. Its key feature is a 0.005-micron pore size, which effectively traps these contaminants. This filtration capability ensures water purity suitable for medical and clinical uses like wound cleansing, surgical handwashing, and equipment cleaning, aligning with standards for dialysis-quality water and microbiological safety.
Is the DSU Dual Stage Ultrafilter designed for single-use or reusable applications, and how long does it remain effective?
The DSU Dual Stage Ultrafilter is supplied as a reusable or replaceable cartridge system, meaning it can be integrated into point-of-use or inline water treatment setups. Under specified conditions, it retains its filtration effectiveness for up to 180 days, though proper storage and handling are required to maintain performance and compliance with manufacturer guidelines.
What regulatory pathway was followed for the DSU Dual Stage Ultrafilter, and which advisory committees were involved?
The DSU Dual Stage Ultrafilter followed the FDA 510(k) pathway, achieving substantial equivalence clearance under the classification 876.5665 (Water Purification Subsystem). The device was reviewed by the Gastroenterology and Urology (GU) Advisory Committee during its evaluation, though this does not imply clinical indications in those specialties. The clearance number is K090885, granted on June 29, 2009.
How should the DSU Dual Stage Ultrafilter be stored to ensure proper function and compliance?
While the DSU Dual Stage Ultrafilter is not sterile by design, its performance depends on adherence to manufacturer-provided storage and handling guidelines. These instructions are critical to maintaining filtration integrity, especially for applications requiring high-purity water. The device is intended for use following other water treatment processes (e.g., reverse osmosis) and must be stored under conditions that preserve its 0.005-micron filtration capability.
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: DSU-H Ultrafilter - Nephros, DSU-D UltraFilter | Nephros, Nephros Dual Stage Ultrafilter - AmeriWater
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090885 | Class II | Active |
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Manufacturer
- Manufacturer
- Nephros, Inc.
Sources (1)
- FDA 510(k) K090885 24 fields · synced Sep 20, 2026