Cleared Traditional

K121409 - ASAHI REXEED-SX/LX SERIES DIALYZER

K121409 is an FDA 510(k) clearance for ASAHI REXEED-SX/LX SERIES DIALYZER, manufactured by Asahi Kasei Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K121409 · Asahi Kasei Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
271d
Days
Class 2
Risk

K121409 is an FDA 510(k) clearance for the ASAHI REXEED-SX/LX SERIES DIALYZER. 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. (Charlestown, US). The FDA issued a Cleared decision on February 6, 2013 after a review of 271 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Asahi Kasei Medical Co., Ltd. devices

FDA 510(k) Submission Details - K121409

510(k) Number K121409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2012
Decision Date February 06, 2013
Days to Decision 271 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 130d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K121409.
ELISIO-H AND ELISIO-M HEMODIALYZERS
K122347 · Nipro Medical Corporation · May 2013
NXSTAGE SYSTEM ONE
K122051 · Nxstage Medical, Inc. · Apr 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · Nxstage Medical, Inc. · Mar 2013
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
K113023 · Nxstage Medical, Inc. · Dec 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
K121341 · Fresenius Medical Care North America · Dec 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
K120017 · Fresenius Medical Care North America · Feb 2012