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Pear Therapeutics, Inc.

FDA Regulatory Profile

Pear Therapeutics, Inc. has 2 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Pear Therapeutics, Inc." and its spelling variant "Pear Therapeutics".

Latest recall
Z-1925-2021 · Class II · Jun 7, 2021
Latest inspection
Apr 7, 2022 · NAI
Latest 510(k)
Mar 23, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Pear Therapeutics, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Pear Therapeutics, Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300000
202210000
202100020
202000000
201910000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

2 recall records on Jun 7, 2021.

NumberClassProductDate
Z-1925-2021Class IIreSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse…Jun 7, 2021
Z-1926-2021Class IIreSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance…Jun 7, 2021

Recent FDA inspections

2 inspections from Apr 23, 2019 to Apr 7, 2022.

DateSiteProductClassificationFEI
Apr 7, 2022Boston, MADevicesNo Action Indicated (NAI)3016159252
Apr 23, 2019San Francisco, CADevicesNo Action Indicated (NAI)3014109807
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3016159252Boston, MA1Apr 7, 2022
FEI 3014109807San Francisco, CA1Apr 23, 2019

Recent 510(k) clearances

3 510(k) clearances from Sep 14, 2017 to Mar 23, 2020.

K-NumberDeviceDate
K191716SomrystMar 23, 2020
K173681reSET-ODec 10, 2018
DEN160018reSetSep 14, 2017

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.