Cleared Traditional

K962707 - MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET

K962707 is an FDA 510(k) clearance for MINNTECH MINNIFILTER PLUS HEMOFILTER AN..., 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 89-day FDA review.

K962707 · Minntech Corp. · Gastroenterology & Urology device
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Oct 1996
Decision
89d
Days
Class 2
Risk

K962707 is an FDA 510(k) clearance for the MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET. 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 October 9, 1996 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Minntech Corp. devices

FDA 510(k) Submission Details - K962707

510(k) Number K962707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1996
Decision Date October 09, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 131d · This submission: 89d
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 K962707.
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K960474 · Cobe Renal Care, Inc. · Aug 1996
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
K954987 · Althin Medical AB an Affiliate of Baxter Intl · Aug 1996