Cleared Special

K002277 - FRESENIUS OPTIFLUX 200NR

K002277 is an FDA 510(k) clearance for FRESENIUS OPTIFLUX 200NR, 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 30-day FDA review.

K002277 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
30d
Days
Class 2
Risk

K002277 is an FDA 510(k) clearance for the FRESENIUS OPTIFLUX 200NR. 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 August 25, 2000 after a review of 30 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 - K002277

510(k) Number K002277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2000
Decision Date August 25, 2000
Days to Decision 30 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
101d faster than avg
Panel avg: 131d · This submission: 30d
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 K002277.
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp. · Feb 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · Nxstage Medical, Inc. · Jan 2001
FRESENIUS OPTIFLUX 200A
K003498 · Fresenius Medical Care North America · Jan 2001
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
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
K001156 · Gambro Renal Products · Jul 2000