Cleared Traditional

K161304 - EndoPur Filter

K161304 is an FDA 510(k) clearance for EndoPur Filter, manufactured by Nephros, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K161304 · Nephros, Inc. · Gastroenterology & Urology device
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Mar 2017
Decision
296d
Days
Class 2
Risk

K161304 is an FDA 510(k) clearance for the EndoPur 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 March 2, 2017 after a review of 296 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nephros, Inc. devices

FDA 510(k) Submission Details - K161304

510(k) Number K161304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2016
Decision Date March 02, 2017
Days to Decision 296 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 131d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FIP Subsystem, Water Purification

All 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K161304.
Millenium HX
K192398 · Mar Cor Purification, Inc. · Oct 2019
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
Matrix Pre-Treatment Controller
K161844 · Better Water, LLC · Dec 2016
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
K153329 · Med-Tech Water Systems, Inc. · Aug 2016
AquaC UNO H
K143617 · Vivonic GmbH · Oct 2015