Cleared Traditional

K926568 - BAXTER CT DIALYZER

K926568 is the FDA 510(k) clearance for BAXTER CT DIALYZER by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 638-day FDA review.

K926568 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Sep 1994
Decision
638d
Days
Class 2
Risk

K926568 is an FDA 510(k) clearance for the BAXTER CT DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 638 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K926568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date September 30, 1994
Days to Decision 638 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
508d slower than avg
Panel avg: 130d · This submission: 638d
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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K926568.
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · Minntech Corp. · Oct 1996
RMI HEMOCONCENTRATOR
K951344 · Research Medical, Inc. · Aug 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · Baxter Healthcare Corp · Apr 1995
PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000
K923727 · Minntech Corp. · Jul 1994
HEMOCOR HP HEMOCONCENTRATOR SERIES
K923139 · Minntech Corp. · Feb 1994
HIGH PERMEABILITY DIALYER
K923312 · Minntech Corp. · Feb 1994