Cleared Special

K043244 - FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR

K043244 is an FDA 510(k) clearance for FRESENIUS OPTIFLUX F20NR, manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 27-day FDA review.

K043244 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
27d
Days
Class 2
Risk

K043244 is an FDA 510(k) clearance for the FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on December 20, 2004 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fresenius Medical Care North America devices

FDA 510(k) Submission Details - K043244

510(k) Number K043244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date December 20, 2004
Days to Decision 27 days
Submission Type Special
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
104d faster than avg
Panel avg: 131d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K043244.
OLPUR DIALYZER, MODEL HD 190
K050603 · Nephros, Inc. · Jun 2005
REXEED SERIES DIALYZERS
K051187 · Asahi Kasei Medical Co., Ltd. · Jun 2005
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
K042938 · Gambro Renal Products · Jan 2005
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
K041005 · Gambro Renal Products · Oct 2004
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
K041726 · Asahi Medical Co., Ltd. · Jul 2004
NXSTAGE SYSTEM ONE
K041424 · Nxstage Medical, Inc. · Jul 2004