Cleared Traditional

K053539 - MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576

K053539 is an FDA 510(k) clearance for MERIDIAN HEMODIALYSIS MACHINE, manufactured by Baxter Healthcare Corporation. The device is a Class 2 Gastroenterology & Urology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K053539

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
24d slower than avg
Panel avg: 131d · This submission: 155d
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 296
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K053539.
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · Baxter Healthcare Corporation · Oct 2006
PRISMA SYSTEM R03.10A
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NXSTAGE CARTRIDGE EXPRESS
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GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
K060195 · Gambro Renal Products · Apr 2006
AQUADEX FLEXFLOW SYSTEM
K060008 · Chf Solutions, Inc. · Feb 2006
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · Minntech Corp. · Jan 2006