Not Cleared Direct

reSet (DEN160018) - FDA 510(k) Clearance

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

DEN160018 · Pear Therapeutics, Inc. · Neurology device
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Sep 2017
Decision
486d
Days
Class 2
Risk

DEN160018 is an FDA 510(k) submission (not cleared) for the reSet. Classified as Computerized Behavioral Therapy Device For Substance Use Disorders (product code PWE), Class II - Special Controls.

Submitted by Pear Therapeutics, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on September 14, 2017 after a review of 486 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5801 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 486 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 Pear Therapeutics, Inc. devices

Submission Details

510(k) Number DEN160018 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 16, 2016
Decision Date September 14, 2017
Days to Decision 486 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 148d · This submission: 486d
Pathway characteristics

Device Classification

Product Code PWE Computerized Behavioral Therapy Device For Substance Use Disorders
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5801
Definition The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Substance Use Disorder.
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.