510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173681Substantially Equivalent

reSET-O

Pear Therapeutics, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173681 is the FDA 510(k) clearance record for reSET-O, a class II device, cleared for Pear Therapeutics, Inc. on under FDA product code PWE (Computerized Behavioral Therapy Device For Substance Use Disorders). FDA's definition for product code PWE reads: "The device is intended to provide cognitive behavioral therapy to treat substance use disorder". FDA records list 3 510(k) clearances for Pear Therapeutics, Inc., from to . As of , FDA records show 2 recalls naming K173681.

Clearance record

Decision date
Received
(374 days to decision)
Product code
PWE Computerized Behavioral Therapy Device For Substance Use Disorders
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Applicant
Pear Therapeutics, Inc. 745 Atlantic Ave., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWE

Trailing 12 months

FDA records hold no clearances under product code PWE in the trailing twelve months.

FDA records show no clearances under product code PWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260