Cleared Traditional

K062079 - XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 (FDA 510(k) Clearance)

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

K062079 · Baxter Healthcare Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
90d
Days
Class 2
Risk

K062079 is an FDA 510(k) clearance for the XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on October 19, 2006 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 Baxter Healthcare Corporation devices

Submission Details

510(k) Number K062079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2006
Decision Date October 19, 2006
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 342
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K062079.
ELISIO™-H
K260533 · Nipro Medical Corporation · Mar 2026
multiFlux 130 (F00013123)
K252459 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · Outset Medical, Inc. · Jan 2026
FX CorAL 40
K253518 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2025
Purema H Hemoconcentrator - Pediatric
K243920 · Medica USA, Inc. · Sep 2025
AK 98 Dialysis Machine (955607)
K250508 · Vantive US Healthcare, LLC · Aug 2025