Not Cleared Direct

DEN150001 - RELIZORB (FDA 510(k) Clearance)

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

DEN150001 · Alcresta, Inc. · Gastroenterology & Urology device
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Nov 2015
Decision
322d
Days
Class 2
Risk

DEN150001 is an FDA 510(k) submission (not cleared) for the RELIZORB. Classified as Enzyme Packed Cartridge (product code PLQ), Class II - Special Controls.

Submitted by Alcresta, Inc. (Newton, US). The FDA issued a Not Cleared (DENG) decision on November 20, 2015 after a review of 322 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5985 - 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 322 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.

View all Alcresta, Inc. devices

Submission Details

510(k) Number DEN150001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 02, 2015
Decision Date November 20, 2015
Days to Decision 322 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
192d slower than avg
Panel avg: 130d · This submission: 322d
Pathway characteristics

Device Classification

Product Code PLQ Enzyme Packed Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5985
Definition Hydrolyze Fats In Enteral Formula.
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.