Cleared Special

K083778 - XENIUM XPH

K083778 is the FDA 510(k) clearance for XENIUM XPH by Baxter Healthcare Corporation. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Special 510(k) pathway after a 63-day FDA review.

K083778 · Baxter Healthcare Corporation · Gastroenterology & Urology device
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Feb 2009
Decision
63d
Days
Class 2
Risk

K083778 is an FDA 510(k) clearance for the XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 63 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 Baxter Healthcare Corporation devices

Submission Details

510(k) Number K083778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2008
Decision Date February 20, 2009
Days to Decision 63 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: 130d · This submission: 63d
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 198
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