Cleared Traditional

NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER

K112314 · Nephros, Inc. · Gastroenterology & Urology

Apr 2012

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K112314 is an FDA 510(k) clearance for the NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Nephros, Inc. (River Edge, US). The FDA issued a Cleared decision on April 27, 2012, 260 days after receiving the submission on August 11, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K112314 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2011
Decision Date	April 27, 2012
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860