Cleared Traditional

K101715 - FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

K101715 is an FDA 510(k) clearance for FRESENIUS 2008T HEMODIALYSIS MACHINE MO..., manufactured by Fresenius Medical Care North America, Design Cente. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K101715 · Fresenius Medical Care North America, Design Cente · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
186d
Days
Class 2
Risk

K101715 is an FDA 510(k) clearance for the 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, Design Cente (Waltham, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 186 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Medical Care North America, Design Cente devices

FDA 510(k) Submission Details - K101715

510(k) Number K101715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2010
Decision Date December 21, 2010
Days to Decision 186 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 131d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 295
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K101715.
PRISMAFLEX
K110823 · Gambro Renal Products, Inc. · Jun 2011
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
K103832 · Gambro Renal Products, Inc. · May 2011
VENOFER PUMP
K103564 · Renal Solutions, Inc. · Feb 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