Cleared Traditional

OPTIFLUX F250NR, MODEL 0500325E

K082414 · Fresenius Medical Care North America · Gastroenterology & Urology

Oct 2008

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K082414 is an FDA 510(k) clearance for the OPTIFLUX F250NR, MODEL 0500325E, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care North America (Waltham,, US). The FDA issued a Cleared decision on October 28, 2008, 68 days after receiving the submission on August 21, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K082414 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2008
Decision Date	October 28, 2008
Days to Decision	68 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