Cleared Special

K110285 - NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (FDA 510(k) Clearance)

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

K110285 · Nephros, Inc. · Gastroenterology & Urology device
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Jul 2011
Decision
164d
Days
Class 2
Risk

K110285 is an FDA 510(k) clearance for the NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Nephros, Inc. (River Edge, US). The FDA issued a Cleared decision on July 14, 2011 after a review of 164 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 K110285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date July 14, 2011
Days to Decision 164 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
34d slower than avg
Panel avg: 130d · This submission: 164d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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.

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