Cleared Special

K071854 - AQUADEX FLEXFLOW SYSTEM

K071854 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 64-day FDA review.

K071854 · Chf Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
64d
Days
Class 2
Risk

K071854 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 September 7, 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.

FDA 510(k) Submission Details - K071854

510(k) Number K071854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date September 07, 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 131d · This submission: 64d
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 345
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K071854.
PRISMAFLEX SYSTEM, VERSION 3.20
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MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
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K072232 · Gambro Renal Products, Inc. · Sep 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · Nxstage Medical, Inc. · Aug 2007
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
K071518 · B. Braun Medizintechnologie GmbH · Aug 2007
K071854 · AQUADEX FLEXFLOW SYSTEM
Download PDF FDA Summary Chf Solutions, Inc.