Cleared Special

K120017 - FRESENIUS 2008 HEMODIAYSIS MACHINE WITH...

K120017 is the FDA 510(k) clearance for FRESENIUS 2008 HEMODIAYSIS MACHINE WITH... 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 30-day FDA review.

K120017 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
30d
Days
Class 2
Risk

K120017 is an FDA 510(k) clearance for the FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM. 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 February 2, 2012 after a review of 30 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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K120017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date February 02, 2012
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 K120017.
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · Nxstage Medical, Inc. · Mar 2013
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
K113023 · Nxstage Medical, Inc. · Dec 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
K121341 · Fresenius Medical Care North America · Dec 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
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
K093902 · Fresenius Medical Care North America · May 2010