# K231209: Rejoyn

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka America Pharmaceutical, Inc.
- Decided: Mar 30, 2024 after 338 days
- Product code: SAP (Computerized Behavioral Therapy Device For Depressive Disorders.)
- Device class: 2
- Regulation: 21 CFR 882.5801
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160018 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160018: reSet, Pear Therapeutics, Inc. (2017) Summary page 4.

## Most influential descendants
- K254038: Motivista (CT-155) (2026), 0 descendants of its own

## Indications for use
Rejoyn is a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

Source page: https://510kreport.com/device/K231209
Methodology: https://510kreport.com/methodology