Cleared Special

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 (K090682) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090682 · Edwards Lifesciences Services GmbH · Gastroenterology & Urology device
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Nov 2009
Decision
248d
Days
Class 2
Risk

K090682 is an FDA 510(k) clearance for the EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Edwards Lifesciences Services GmbH (Welwyn Garden City, GB). The FDA issued a Cleared decision on November 19, 2009 after a review of 248 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Edwards Lifesciences Services GmbH devices

Submission Details

510(k) Number K090682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date November 19, 2009
Days to Decision 248 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
118d slower than avg
Panel avg: 130d · This submission: 248d
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.

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