De Novo · Granted
GrantedreSet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pear Therapeutics, Inc. · PWE Computerized Behavioral Therapy Device For Substance Use Disorders
Granted on Sep 14, 2017 as a new device type through De Novo after a 486-day review. 6 later devices descend from it.
- Decided
- Sep 14, 2017
- Review
- 486 days
- Class
- Class II
- Product code
- PWE
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN160018 reSetPear Therapeutics, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK191716 SomrystPear Therapeutics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK231209 RejoynOtsuka America Pharmaceutical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK254038 Motivista (CT-155)Click Therapeutics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK233872 DaylightBig Health, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233577 Sleepio®Big Health, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191716SomrystPear Therapeutics, Inc. · 2020 · cites it directly3descendants
- K231209RejoynOtsuka America Pharmaceutical, Inc. · 2024 · cites it directly1descendant
- K254038Motivista (CT-155)Click Therapeutics, Inc. · 2026 · 2 generations on0descendants
- K233872DaylightBig Health, Inc. · 2024 · 2 generations on0descendants
- K233577Sleepio®Big Health, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160018 | reSet | Pear Therapeutics, Inc. | 2017 | — |
| +1 | K191716 | Somryst | Pear Therapeutics, Inc. | 2020 | — |
| +1 | K231209 | Rejoyn | Otsuka America Pharmaceutical, Inc. | 2024 | — |
| +2 | K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | 2026 | — |
| +2 | K233872 | Daylight | Big Health, Inc. | 2024 | — |
| +2 | K233577 | Sleepio® | Big Health, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K191716 (Pear Therapeutics, Inc., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All PWE devicesPWE Computerized Behavioral Therapy Device For Substance Use Disorders: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PWE
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PWE
Too few PWE 510(k)s in any year since 2007 to give a median.
Recalls per year · PWE
No recall names PWE since 2007.
Adverse event reports per year · PWE
1in 2025
MAUDE reports naming product code PWE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160018 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160018: reSet.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160018
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026