Cleared Special

K161467 - HydraGuard 10 UltraFilter (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161467 · Nephros, Inc. · Gastroenterology & Urology device
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Dec 2016
Decision
209d
Days
Class 2
Risk

K161467 is an FDA 510(k) clearance for the HydraGuard 10 UltraFilter. Classified as System, Water Purification, General Medical Use (product code NHV), Class II - Special Controls.

Submitted by Nephros, Inc. (River Edge, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 209 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nephros, Inc. devices

Submission Details

510(k) Number K161467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2016
Decision Date December 22, 2016
Days to Decision 209 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 130d · This submission: 209d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHV System, Water Purification, General Medical Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
Definition The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.