Cleared Special

K040489 - AQUADEX SYSTEM 100

K040489 is an FDA 510(k) clearance for AQUADEX SYSTEM 100, manufactured by Chf Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 61-day FDA review.

K040489 · Chf Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
61d
Days
Class 2
Risk

K040489 is an FDA 510(k) clearance for the AQUADEX SYSTEM 100, MODEL A1100. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Chf Solutions, Inc. (Brooklyn Park, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 61 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 Chf Solutions, Inc. devices

FDA 510(k) Submission Details - K040489

510(k) Number K040489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date April 27, 2004
Days to Decision 61 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
69d faster than avg
Panel avg: 130d · This submission: 61d
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 K040489.
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
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NXSTAGE SYSTEM ONE
K041424 · Nxstage Medical, Inc. · Jul 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · Nxstage Medical, Inc. · May 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · Fresenius Medical Care North America · Jan 2004
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · Nxstage Medical, Inc. · Oct 2003
PRISMA M60/M100 SETS
K032431 · Gambro, Inc. · Sep 2003