Cleared Traditional

K153449 - 2008K2 Hemodialysis Machine

K153449 is an FDA 510(k) clearance for 2008K2 Hemodialysis Machine, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K153449 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K153449

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
Combination Product No
PCCP Authorized No
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.

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 244
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K153449.
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017
Optiflux dialyzer
K162488 · Fresenius Medical Care North America · Apr 2017
FB-U Hemodialyzer
K160444 · Nipro Medical Corporation · Feb 2017
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
K150708 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2015
Optiflux dialyzer
K152367 · Fresenius Medical Care North America · Oct 2015
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
K143313 · Nxstage Medical, Inc. · Mar 2015