FDA applicant
Pear Therapeutics, Inc.
FDA records 3 decisions for Pear Therapeutics, Inc. (Boston, MA) from 2017 to 2020: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PWE (Computerized Behavioral Therapy Device For…) and QVO (Computerized Behavioral Therapy Device For…). Its devices cite 1 predicate, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pear Therapeutics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
2in 2021
Class I Class II/III not classified
Planning a device like Pear Therapeutics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report