Cleared Special

K120017 - FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM

K120017 is an FDA 510(k) clearance for FRESENIUS 2008 HEMODIAYSIS MACHINE WITH..., manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K120017

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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KDI Device Classification - Class 2, Special Controls

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 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K120017.
VENOFER PUMP
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K120505 · Fresenius Medical Care North America, Design Cente · Mar 2012
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K113427 · Fresenius Medical Care North America · Dec 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
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PRISMAFLEX
K110823 · Gambro Renal Products, Inc. · Jun 2011