Cleared Traditional

K980859 - HEMOCOR HPH MINI HEMOCONCENTRATOR

K980859 is an FDA 510(k) clearance for HEMOCOR HPH MINI HEMOCONCENTRATOR, 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 68-day FDA review.

K980859 · Minntech Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
68d
Days
Class 2
Risk

K980859 is an FDA 510(k) clearance for the HEMOCOR HPH MINI 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 May 12, 1998 after a review of 68 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 - K980859

510(k) Number K980859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date May 12, 1998
Days to Decision 68 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
63d faster than avg
Panel avg: 131d · This submission: 68d
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 K980859.
DIALOG DIALYSIS MACHINE
K963440 · B. Braun Medical AG · Jun 1998
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
K980656 · Baxter Healthcare Corp · May 1998
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
K974584 · Fresenius USA, Inc. · May 1998
CAPIOX HEMOCONCENTRATOR
K973516 · Terumo Medical Corp. · Jan 1998
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
K970253 · Gambro Healthcare · Sep 1997
BLOOD MONITOR PUMP
K970591 · Baxter Healthcare Corp · Sep 1997