Cleared Traditional

K071298 - HF JUNIOR HEMOFILTER

K071298 is an FDA 510(k) clearance for HF JUNIOR HEMOFILTER, manufactured by Minntech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K071298 · Minntech Corp. · Gastroenterology & Urology device
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Aug 2007
Decision
91d
Days
Class 2
Risk

K071298 is an FDA 510(k) clearance for the HF JUNIOR HEMOFILTER. 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 August 8, 2007 after a review of 91 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 Minntech Corp. devices

FDA 510(k) Submission Details - K071298

510(k) Number K071298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2007
Decision Date August 08, 2007
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
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 270
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K071298.
OPTIFLUX F250NR, MODEL 0500325E
K082414 · Fresenius Medical Care North America · Oct 2008
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · Gambro, Inc. · Nov 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · Nxstage Medical, Inc. · Aug 2007
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
PRISMA SYSTEM R03.10A
K062090 · Gambro Renal Products · Oct 2006