Cleared Traditional

K053539 - MERIDIAN HEMODIALYSIS MACHINE

K053539 is the FDA 510(k) clearance for MERIDIAN HEMODIALYSIS MACHINE by Baxter Healthcare Corporation. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K053539 · Baxter Healthcare Corporation · Gastroenterology & Urology device
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May 2006
Decision
155d
Days
Class 2
Risk

K053539 is an FDA 510(k) clearance for the MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on May 24, 2006 after a review of 155 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 Baxter Healthcare Corporation devices

Submission Details

510(k) Number K053539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date May 24, 2006
Days to Decision 155 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
25d slower than avg
Panel avg: 130d · This submission: 155d
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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K053539.
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
K070222 · Fresenius Medical Care North America · Apr 2007
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · Baxter Healthcare Corporation · Oct 2006
NXSTAGE CARTRIDGE EXPRESS
K061837 · Nxstage Medical, Inc. · Jul 2006
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · Minntech Corp. · Jan 2006
NXSTAGE SYSTEM ONE
K050525 · Nxstage Medical, Inc. · Jun 2005
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
K050727 · Nxstage Medical, Inc. · Jun 2005