Pear Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Pear Therapeutics, Inc.” (first 2018, latest 2020), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 322 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 374 |
| 2019 | 0 | — |
| 2020 | 1 | 271 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pear Therapeutics, Inc. took a median 322 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 272 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PWE | Computerized Behavioral Therapy Device For Substance Use Disorders | 2 | 1 |
| QVO | Computerized Behavioral Therapy Device For Insomnia | 1 | 1 |
Review panels
- Neurology (3)
Most recent Pear Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191716 | Somryst | QVO | 2020-03-23 | 271 |
| K173681 | reSET-O | PWE | 2018-12-10 | 374 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160018 | De Novo | Computerized Behavioral Therapy Device For Substance Use Disorders | 2017-09-14 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-06-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Pear Therapeutics, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05412966: Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence (Completed, started 2022-11-04)
- NCT04542642: A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic (Completed, started 2021-05-19)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pear Therapeutics, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Pear Therapeutics, Inc.” (first 2018, latest 2020), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pear Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pear Therapeutics, Inc. is 322 days.
Which FDA product codes appear under Pear Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are PWE (Computerized Behavioral Therapy Device For Substance Use Disorders, 2); QVO (Computerized Behavioral Therapy Device For Insomnia, 1).
Next steps
- See all 2 Pear Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PWE, Pear Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.