Not Cleared Direct

DEN200026 - EndeavorRx (FDA 510(k) Clearance)

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

DEN200026 · Akili Interactive Labs, Inc. · Neurology device
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Jun 2020
Decision
60d
Days
Class 2
Risk

DEN200026 is an FDA 510(k) submission (not cleared) for the EndeavorRx. Classified as Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder (product code QFT), Class II - Special Controls.

Submitted by Akili Interactive Labs, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on June 15, 2020 after a review of 60 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5803 - the FDA neurology 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 Neurology review framework.

View all Akili Interactive Labs, Inc. devices

Submission Details

510(k) Number DEN200026 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 16, 2020
Decision Date June 15, 2020
Days to Decision 60 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics

Device Classification

Product Code QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5803
Definition A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment.
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 Neurology devices follow this clearance model.