Cleared Traditional

K813591 - HEMOFILTERS

K813591 is the FDA 510(k) clearance for HEMOFILTERS by Amicon, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K813591 · Amicon, Inc. · Gastroenterology & Urology device
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Mar 1982
Decision
93d
Days
Class 2
Risk

K813591 is an FDA 510(k) clearance for the HEMOFILTERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Amicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amicon, Inc. devices

Submission Details

510(k) Number K813591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1981
Decision Date March 31, 1982
Days to Decision 93 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
37d faster than avg
Panel avg: 130d · This submission: 93d
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 199
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K813591.
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
K830284 · Gambro, Inc. · Mar 1983
COBE HEMOCONCENTRATOR 1.3
K823338 · Cobe Laboratories, Inc. · Jan 1983
H 12 07
K823589 · Hospal Medical Corp. · Dec 1982
CONTINUOUS BLOOD PROCESSOR CBP-6000 &
K820243 · Bentley Laboratories, Inc. · Mar 1982
MODEL H12-10
K812575 · Hospal Medical Corp. · Oct 1981
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · Cordis Corp. · Sep 1981