Cleared Special

K093902 - MODIFICATION TO:FRESENIUS 2008T HEMODIA...

K093902 is the FDA 510(k) clearance for MODIFICATION TO:FRESENIUS 2008T HEMODIA... by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Special 510(k) pathway after a 156-day FDA review.

K093902 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
156d
Days
Class 2
Risk

K093902 is an FDA 510(k) clearance for the MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on May 27, 2010 after a review of 156 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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K093902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date May 27, 2010
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
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 171
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K093902.
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
K120017 · Fresenius Medical Care North America · Feb 2012
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
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