Cleared Special

K003498 - FRESENIUS OPTIFLUX 200A

K003498 is an FDA 510(k) clearance for FRESENIUS OPTIFLUX 200A, 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 52-day FDA review.

K003498 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
52d
Days
Class 2
Risk

K003498 is an FDA 510(k) clearance for the FRESENIUS OPTIFLUX 200A. 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 January 4, 2001 after a review of 52 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 - K003498

510(k) Number K003498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date January 04, 2001
Days to Decision 52 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
79d faster than avg
Panel avg: 131d · This submission: 52d
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 K003498.
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp. · Feb 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · Nxstage Medical, Inc. · Jan 2001
FRESENIUS OPTIFLUX 200NR
K002277 · Fresenius Medical Care North America · Aug 2000
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · Toray Industries (America), Inc. · Aug 2000
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
K001250 · Asahi Medical Co., Ltd. · Aug 2000