Cleared Special

K060008 - AQUADEX FLEXFLOW SYSTEM

K060008 is an FDA 510(k) clearance for AQUADEX FLEXFLOW SYSTEM, 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 30-day FDA review.

K060008 · Chf Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
30d
Days
Class 2
Risk

K060008 is an FDA 510(k) clearance for the AQUADEX FLEXFLOW SYSTEM. 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 Mn, US). The FDA issued a Cleared decision on February 2, 2006 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 Chf Solutions, Inc. devices

FDA 510(k) Submission Details - K060008

510(k) Number K060008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2006
Decision Date February 02, 2006
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
101d faster than avg
Panel avg: 131d · 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 295
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K060008.
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K050952 · Minntech Corp. · Jan 2006
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AQUADEX SYSTEM
K050609 · Chf Solutions, Inc. · Nov 2005