Cleared Traditional

K884326 - FILTRAL TM 8 HEMODIALYZER

K884326 is the FDA 510(k) clearance for FILTRAL TM 8 HEMODIALYZER by Hospal Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K884326 · Hospal Medical Corp. · Gastroenterology & Urology device
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Dec 1988
Decision
52d
Days
Class 2
Risk

K884326 is an FDA 510(k) clearance for the FILTRAL TM 8 HEMODIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (Edison, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 52 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 Hospal Medical Corp. devices

Submission Details

510(k) Number K884326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date December 05, 1988
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K884326.
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · Fresenius USA, Inc. · Apr 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · Baxter Healthcare Corp · Feb 1989
MULTIFLOW(TM) 60 KIT
K884365 · Hospal Medical Corp. · Dec 1988
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · Hospal Medical Corp. · Oct 1988
FRESENIUS F8 DIALYZER
K883195 · Fresenius USA, Inc. · Sep 1988
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · Hospal Medical Corp. · Dec 1987