# DEN160018: reSet

- Pathway: De Novo (Direct)
- Applicant: Pear Therapeutics, Inc.
- Decided: Sep 14, 2017 after 486 days
- Product code: PWE (Computerized Behavioral Therapy Device For Substance Use Disorders)
- Device class: 2
- Regulation: 21 CFR 882.5801
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191716: Somryst (2020), 3 descendants of its own
- K231209: Rejoyn (2024), 1 descendant of its own
- K254038: Motivista (CT-155) (2026), 0 descendants of its own
- K233872: Daylight (2024), 0 descendants of its own
- K233577: Sleepio® (2024), 0 descendants of its own

## Indications for use
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: • increase abstinence from a patient’s substances of abuse during treatment, and • increase retention in the outpatient treatment program.

Source page: https://510kreport.com/device/DEN160018
Methodology: https://510kreport.com/methodology