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HydraGuard 10 UltraFilter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161467

by Nephros, Inc.

Identifiers

510(k) Number
K161467 FDA 510(k)
FDA Product Code
NHV 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 HydraGuard 10 UltraFilter is a hollow fiber point-of-use ultrafilter designed to remove bacteria, viruses, and endotoxins from water through size exclusion. It is intended to filter EPA-quality drinking water to provide ultrapure water for patient washing and drinking. The device is classified as a Class II medical device under the product code NHV and is regulated for general medical use in gastroenterology and urology settings.

The HydraGuard 10 UltraFilter is supplied as a single-use, sterile device and is intended for point-of-use installation in clinical environments. It is designed for use with EPA-quality water and offers 5-log endotoxin retention for up to 6 months. The device is authorized under FDA 510(k) clearance with the reference number K161467 and is manufactured by Nephros, Inc. in River Edge, NJ.

Frequently asked questions

What type of water can the HydraGuard 10 UltraFilter be used with?

It is designed for point‑of‑use installation with EPA‑quality drinking water. Using water that meets EPA standards ensures the filter’s size‑exclusion mechanism can reliably remove microorganisms and endotoxins without exceeding its performance limits.

Is the HydraGuard 10 UltraFilter sterile and intended for multiple uses?

The device is supplied sterile and labeled for single‑use only. Sterility guarantees that no external contaminants are introduced during patient washing or drinking, and single‑use eliminates the risk of performance degradation that can occur with repeated handling.

How long does the filter maintain its endotoxin removal capability?

It provides a 5‑log endotoxin retention capacity for up to six months when used with EPA‑quality water. This duration reflects the filter’s validated lifespan under typical clinical conditions, after which replacement is recommended to maintain ultrapure water quality.

In which clinical specialties is the HydraGuard 10 UltraFilter regulated for use?

Regulatory filings list gastroenterology and urology as the advisory committee specialties, indicating the device is intended for general medical use in those areas, such as patient washing and drinking water preparation in related procedures.

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: HydraGuard UltraFilter - Nephros, PDF Instructions for Use Part #: 70-0112 H ydraGuard 10" UltraFilter - F, Nephros 70-0111 HydraGuard 10-Inch Ultrafilter - 222 O-Ring, Infection ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nephros, Inc.

Sources (1)

  • FDA 510(k) K161467 24 fields · synced Sep 25, 2026