Cleared Traditional

K070320 - EDWARDS AQUARIUS HEMOFILTRATION SYSTEM

K070320 is an FDA 510(k) clearance for EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, manufactured by Edwards Lifesciences Services GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K070320 · Edwards Lifesciences Services GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
125d
Days
Class 2
Risk

K070320 is an FDA 510(k) clearance for the EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Edwards Lifesciences Services GmbH (Stevenage, GB). The FDA issued a Cleared decision on June 7, 2007 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences Services GmbH devices

FDA 510(k) Submission Details - K070320

510(k) Number K070320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2007
Decision Date June 07, 2007
Days to Decision 125 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 130d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070320.
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · Gambro, Inc. · Nov 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · Nxstage Medical, Inc. · Aug 2007
HF JUNIOR HEMOFILTER
K071298 · Minntech Corp. · Aug 2007
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
K070222 · Fresenius Medical Care North America · Apr 2007
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · Baxter Healthcare Corporation · Oct 2006
NXSTAGE CARTRIDGE EXPRESS
K061837 · Nxstage Medical, Inc. · Jul 2006