Cleared Special

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX (K041726) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041726 · Asahi Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
28d
Days
Class 2
Risk

K041726 is an FDA 510(k) clearance for the HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, .... Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Asahi Medical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on July 23, 2004 after a review of 28 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 Medical Co., Ltd. devices

Submission Details

510(k) Number K041726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2004
Decision Date July 23, 2004
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 343
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K041726.
NxStage System One with NxView
K252377 · Fresenius Medical Care Renal Therapies Group, LLC · May 2026
ELISIO™-H
K260533 · Nipro Medical Corporation · Mar 2026
multiFlux 130 (F00013123)
K252459 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · Outset Medical, Inc. · Jan 2026
FX CorAL 40
K253518 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2025
Purema H Hemoconcentrator - Pediatric
K243920 · Medica USA, Inc. · Sep 2025