Cleared Traditional

K910236 - RENAFLO HDF 1350 HEMODIAFILTER

K910236 is an FDA 510(k) clearance for RENAFLO HDF 1350 HEMODIAFILTER, 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 81-day FDA review.

K910236 · Minntech Corp. · Gastroenterology & Urology device
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Apr 1991
Decision
81d
Days
Class 2
Risk

K910236 is an FDA 510(k) clearance for the RENAFLO HDF 1350 HEMODIAFILTER. 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 April 9, 1991 after a review of 81 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 - K910236

510(k) Number K910236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1991
Decision Date April 09, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 131d · This submission: 81d
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 K910236.
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K900018 · National Medical Care, Medical Products Div., Inc. · Jul 1990