Not Cleared Direct

DEN200029 - Parallel (FDA 510(k) Clearance)

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

DEN200029 · Mahana Therapeutics, Inc. · Gastroenterology & Urology device
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Nov 2020
Decision
209d
Days
Class 2
Risk

DEN200029 is an FDA 510(k) submission (not cleared) for the Parallel. Classified as Computerized Behavioral Therapy Device For Treating Symptoms (product code QMY), Class II - Special Controls.

Submitted by Mahana Therapeutics, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on November 25, 2020 after a review of 209 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5960 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Mahana Therapeutics, Inc. devices

Submission Details

510(k) Number DEN200029 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 30, 2020
Decision Date November 25, 2020
Days to Decision 209 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
79d slower than avg
Panel avg: 130d · This submission: 209d
Pathway characteristics

Device Classification

Product Code QMY Computerized Behavioral Therapy Device For Treating Symptoms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5960
Definition A Computerized Behavioral Therapy Device For Treating Symptoms Of Gastrointestinal Conditions Is A Prescription Device Intended To Provide A Computerized Version Of Condition-specific Therapy As An Adjunct To Standard Of Care Treatments To Patients With Gastrointestinal Conditions.
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.