Cleared Traditional

K091360 - CLEARFLUX DIALYZER REPROCESSING SYSTEM

K091360 is an FDA 510(k) clearance for CLEARFLUX DIALYZER REPROCESSING SYSTEM, manufactured by Novaflux Technologies. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 544-day FDA review.

K091360 · Novaflux Technologies · Gastroenterology & Urology device
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Nov 2010
Decision
544d
Days
Class 2
Risk

K091360 is an FDA 510(k) clearance for the CLEARFLUX DIALYZER REPROCESSING SYSTEM. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Novaflux Technologies (Princeton, US). The FDA issued a Cleared decision on November 3, 2010 after a review of 544 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Novaflux Technologies devices

FDA 510(k) Submission Details - K091360

510(k) Number K091360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date November 03, 2010
Days to Decision 544 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
413d slower than avg
Panel avg: 131d · This submission: 544d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - LIF Dialyzer Reprocessing System

All 32
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K091360.
ASSIST HEADER CLEANER
K043126 · Alcavis International, Inc. · Feb 2005
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505 · Minntech Corp. · Apr 2004
AMUKIN D
K992016 · Amuchina Intl., Inc. · Jan 2000
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · Minntech Corp. · Aug 1999
POTENCY TEST STRIPS, INDICATOR TEST STRIPS
K974426 · Reprocessing Products Corp · Feb 1999
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798 · Environmental Test Systems, Inc. · Mar 1998