Cleared Special

K051187 - REXEED SERIES DIALYZERS

K051187 is an FDA 510(k) clearance for REXEED SERIES DIALYZERS, manufactured by Asahi Kasei Medical Co., Ltd.. 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.

K051187 · Asahi Kasei Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jun 2005
Decision
30d
Days
Class 2
Risk

K051187 is an FDA 510(k) clearance for the REXEED SERIES DIALYZERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Asahi Kasei Medical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on June 8, 2005 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 Asahi Kasei Medical Co., Ltd. devices

FDA 510(k) Submission Details - K051187

510(k) Number K051187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2005
Decision Date June 08, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · 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 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K051187.
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · Minntech Corp. · Jan 2006
NXSTAGE SYSTEM ONE
K050525 · Nxstage Medical, Inc. · Jun 2005
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
K050727 · Nxstage Medical, Inc. · Jun 2005
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
K043244 · Fresenius Medical Care North America · Dec 2004
NXSTAGE SYSTEM ONE
K041424 · Nxstage Medical, Inc. · Jul 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · Nxstage Medical, Inc. · May 2004