# K173681: reSET-O

- Pathway: 510(k) (Traditional)
- Applicant: Pear Therapeutics, Inc.
- Decided: Dec 10, 2018 after 374 days
- Product code: PWE (Computerized Behavioral Therapy Device For Substance Use Disorders)
- Device class: 2
- Regulation: 21 CFR 882.5801
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- DEN160018: reSet, Pear Therapeutics, Inc. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Jun 7, 2021 · Class II · Z-1925-2021: Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should
- Jun 7, 2021 · Class II · Z-1926-2021: Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should

## Indications for use
reSET-O™ is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.

Source page: https://510kreport.com/device/K173681
Methodology: https://510kreport.com/methodology