Cleared Traditional

K123262 - OPTIFLUX ULTRA DIALYZER

K123262 is the FDA 510(k) clearance for OPTIFLUX ULTRA DIALYZER by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K123262 · Fresenius Medical Care North America · Gastroenterology & Urology device
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Jan 2014
Decision
445d
Days
Class 2
Risk

K123262 is an FDA 510(k) clearance for the OPTIFLUX ULTRA DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on January 6, 2014 after a review of 445 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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K123262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2012
Decision Date January 06, 2014
Days to Decision 445 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
315d slower than avg
Panel avg: 130d · This submission: 445d
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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K123262.
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K131050 · Nxstage Medical, Inc. · Dec 2013
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K131935 · Nipro Medical Corporation · Dec 2013
ELISIO-H HEMODIALYZER
K131381 · Nipro Medical Corporation · Dec 2013