Cleared Traditional

FRESENIUS 2008K (K994267) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994267 · Fresenius Medical Care · Gastroenterology & Urology device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994267 is an FDA 510(k) clearance for the FRESENIUS 2008K. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care (Lexington, US). The FDA issued a Cleared decision on March 16, 2000 after a review of 90 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 Fresenius Medical Care devices

Submission Details

510(k) Number K994267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1999
Decision Date March 16, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
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 78
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K994267.
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp. · Feb 2001
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · Baxter Healthcare Corp · Jun 2000
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · Baxter Healthcare Corp · Nov 1999
DIAPACT CRRT
K973322 · B.Braun Medical, Inc. · Nov 1998
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · Baxter Healthcare Corp · Jul 1998