510(k) · Cleared
ClearedRejoyn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otsuka America Pharmaceutical, Inc. · SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Cleared on Mar 30, 2024 as substantially equivalent to DEN160018 (Pear Therapeutics, Inc., 2017) after a 338-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Mar 30, 2024
- Review
- 338 days
- Class
- Class II
- Product code
- SAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160018 (2017). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K254038Motivista (CT-155)Click Therapeutics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160018 | reSet | Pear Therapeutics, Inc. | 2017 | — |
| 0 (this device) | K231209 | Rejoyn | Otsuka America Pharmaceutical, Inc. | 2024 | — |
| +1 | K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAP device
- #1 K254038 Motivista (CT-155)score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160018 | reSetSummary page 4…e(s) Predicate Device Common Name: reSET® Predicate Device Manufacturer: Pear Therapeutics, Inc. Predicate Device Premarket Notification #: DEN160018 Predicate Device Classification: Computerized Behavioral Therapy Device for… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254038 | Motivista (CT-155) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All SAP devicesSAP Computerized Behavioral Therapy Device For Depressive Disorders.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SAP
Too few SAP 510(k)s in any year since 2007 to give a median.
Recalls per year · SAP
No recall names SAP since 2007.
Adverse event reports per year · SAP
No MAUDE report names SAP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231209: Rejoyn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231209
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026