Cleared Traditional

K872456 - HEMOCOR PLUS HEMOCONCENTRATOR

K872456 is the FDA 510(k) clearance for HEMOCOR PLUS HEMOCONCENTRATOR by Minntech Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K872456 · Minntech Corp. · Gastroenterology & Urology device
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Sep 1987
Decision
84d
Days
Class 2
Risk

K872456 is an FDA 510(k) clearance for the HEMOCOR PLUS 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 September 15, 1987 after a review of 84 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

Submission Details

510(k) Number K872456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date September 15, 1987
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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 110
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K872456.
FILTRAL TM 8 HEMODIALYZER
K884326 · Hospal Medical Corp. · Dec 1988
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · Hospal Medical Corp. · Oct 1988
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · Hospal Medical Corp. · Dec 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · Gambro, Inc. · May 1987
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
K861776 · Travenol Laboratories, S.A. · Jun 1986
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
K860938 · Gambro, Inc. · Apr 1986