Cleared Special

K070512 - MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

K070512 is the FDA 510(k) clearance for MODIFICATION TO AQUADEX FLEXFLOW SYSTEM by Chf Solutions, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Special 510(k) pathway after a 64-day FDA review.

K070512 · Chf Solutions, Inc. · Gastroenterology & Urology device
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Apr 2007
Decision
64d
Days
Class 2
Risk

K070512 is an FDA 510(k) clearance for the MODIFICATION TO 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 April 27, 2007 after a review of 64 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

Submission Details

510(k) Number K070512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2007
Decision Date April 27, 2007
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
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 188
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