Cleared Special

K093120 - XENIUM XPM 110

K093120 is the FDA 510(k) clearance for XENIUM XPM 110 by Baxter Healthcare Corporation - Renal Division. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Special 510(k) pathway after a 138-day FDA review.

K093120 · Baxter Healthcare Corporation - Renal Division · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
138d
Days
Class 2
Risk

K093120 is an FDA 510(k) clearance for the XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENI.... Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation - Renal Division (Mcgaw Park, US). The FDA issued a Cleared decision on February 17, 2010 after a review of 138 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. 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 Baxter Healthcare Corporation - Renal Division devices

Submission Details

510(k) Number K093120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date February 17, 2010
Days to Decision 138 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
8d slower than avg
Panel avg: 130d · This submission: 138d
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 199
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K093120.
FRESENIUS 2008T HEMODIALYSIS MACHINE
K113427 · Fresenius Medical Care North America · Dec 2011
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
K093069 · Nxstage Medical, Inc. · Oct 2010
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
K093902 · Fresenius Medical Care North America · May 2010
EXALIS, SOFTWARE VERSION 1.15
K083158 · Gambro, Inc. · Jun 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · Baxter Healthcare Corporation · Feb 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · Fresenius Medical Care North America · Jan 2009