Cleared Special

K082515 - ASAHI REXEED-SX/LX DIALYZERS

K082515 is an FDA 510(k) clearance for ASAHI REXEED-SX/LX 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 31-day FDA review.

K082515 · Asahi Kasei Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
31d
Days
Class 2
Risk

K082515 is an FDA 510(k) clearance for the ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15L.... 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 October 3, 2008 after a review of 31 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 - K082515

510(k) Number K082515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date October 03, 2008
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
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 K082515.
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K070643 · Gambro, Inc. · Nov 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · Nxstage Medical, Inc. · Aug 2007
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K071298 · Minntech Corp. · Aug 2007