Cleared Traditional

2008K2 Hemodialysis Machine (K153449) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153449 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
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Apr 2016
Decision
148d
Days
Class 2
Risk

K153449 is an FDA 510(k) clearance for the 2008K2 Hemodialysis Machine. 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 April 26, 2016 after a review of 148 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 K153449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2015
Decision Date April 26, 2016
Days to Decision 148 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
18d slower than avg
Panel avg: 130d · This submission: 148d
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 92
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K153449.
2008T BlueStar Hemodialysis Machine
K173972 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Prismaflex System 8.10
K171671 · Baxter Healthcare Corporation · Feb 2018
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017
EXALIS, SOFTWARE VERSION 1.15
K083158 · Gambro, Inc. · Jun 2009
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · Gambro, Inc. · Nov 2007
PRISMA M60/M100 SETS
K032431 · Gambro, Inc. · Sep 2003