Cleared Traditional

K131908 - 2008T HEMODIALYSIS MACHINE WITH OPTIONA...

K131908 is the FDA 510(k) clearance for 2008T HEMODIALYSIS MACHINE WITH OPTIONA... by Fresenius Medical Care Renal Therapies Group, LLC. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K131908 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
107d
Days
Class 2
Risk

K131908 is an FDA 510(k) clearance for the 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC). Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on October 11, 2013 after a review of 107 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. 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 Renal Therapies Group, LLC devices

Submission Details

510(k) Number K131908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date October 11, 2013
Days to Decision 107 days
Submission Type Traditional
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
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 170
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K131908.
STREAMLINE EXPRESS
K132602 · Nxstage Medical, Inc. · Feb 2014
OPTIFLUX ULTRA DIALYZER
K123262 · Fresenius Medical Care North America · Jan 2014
NXSTAGE 1.6M2 DIALYZER
K131050 · Nxstage Medical, Inc. · Dec 2013
HEMOCONCENTRATOR
K123288 · Maquet Cardiopulmonary, AG · Jun 2013
NXSTAGE SYSTEM ONE
K122051 · Nxstage Medical, Inc. · Apr 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · Nxstage Medical, Inc. · Mar 2013