Cleared Traditional

K864587 - FRESENIUS ULTRAFLUX AV400

K864587 is the FDA 510(k) clearance for FRESENIUS ULTRAFLUX AV400 by Seratronics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K864587 · Seratronics, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
102d
Days
Class 2
Risk

K864587 is an FDA 510(k) clearance for the FRESENIUS ULTRAFLUX AV400, AV600. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Seratronics, Inc. (Concord, US). The FDA issued a Cleared decision on March 3, 1987 after a review of 102 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 Seratronics, Inc. devices

Submission Details

510(k) Number K864587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date March 03, 1987
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
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 K864587.
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · Hospal Medical Corp. · Dec 1987
HEMOCOR PLUS HEMOCONCENTRATOR
K872456 · Minntech Corp. · Sep 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · Gambro, Inc. · May 1987
HOSPAL BIOSPAL 1800S
K863961 · Hospal Medical Corp. · Dec 1986
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