Cleared Traditional

K050952 - HPH JUNIOR HIGH PERFORMANCE HEMOCONCENT...

K050952 is the FDA 510(k) clearance for HPH JUNIOR HIGH PERFORMANCE HEMOCONCENT... by Minntech Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K050952 · Minntech Corp. · Gastroenterology & Urology device
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Jan 2006
Decision
291d
Days
Class 2
Risk

K050952 is an FDA 510(k) clearance for the HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on January 31, 2006 after a review of 291 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 Minntech Corp. devices

Submission Details

510(k) Number K050952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2005
Decision Date January 31, 2006
Days to Decision 291 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
161d slower than avg
Panel avg: 130d · This submission: 291d
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 106
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K050952.
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · Gambro, Inc. · Nov 2007
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · Baxter Healthcare Corporation · Oct 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K053539 · Baxter Healthcare Corporation · May 2006
PRISMA M60/M100 SETS
K032431 · Gambro, Inc. · Sep 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · Baxter Healthcare Corp · Jun 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · Baxter Healthcare Corp · Apr 2003