Not Cleared Direct

DEN190042 - Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190042 · Baxter Healthcare Corporation · Gastroenterology & Urology device
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Aug 2020
Decision
347d
Days
Class 2
Risk

DEN190042 is an FDA 510(k) submission (not cleared) for the Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer. Classified as Hemodialyzer With Expanded Solute Removal Profile (product code QAX), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Not Cleared (DENG) decision on August 28, 2020 after a review of 347 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5862 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 347 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN190042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 16, 2019
Decision Date August 28, 2020
Days to Decision 347 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 130d · This submission: 347d
Pathway characteristics

Device Classification

Product Code QAX Hemodialyzer With Expanded Solute Removal Profile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5862
Definition A Hemodialyzer With Expanded Solute Removal Profile Is Intended For Use As Part Of An Artificial Kidney System For The Treatment Of Patients With Renal Failure By Performing Such Therapies As Hemodialysis, Hemofiltration, And Hemodiafiltration. A Hemodialyzer With Expanded Solute Removal Profile Includes Modifications To The Semipermeable Membrane That Allows For Increased Removal Of Uremic Retention Solutes Compared With Standard High-flux Hemodialyzers Of The High Permeability Hemodialysis System Classification (21 Cfr §876.5860), Including Solutes At The Upper End Of The “middle” Molecular Weight Range (0.5 Kda To 60 Kda).
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.