510(k) · Cleared
ClearedMotivista (CT-155)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Click Therapeutics, Inc. · SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Cleared on Jul 30, 2026 as substantially equivalent to K231209 (Otsuka America Pharmaceutical, Inc., 2024) after a 226-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Jul 30, 2026
- Review
- 226 days
- Class
- Class II
- Product code
- SAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160018 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K231209 Rejoynscore 10.1 · 1 generation · 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 |
|---|---|---|---|
| * | K231209 | RejoynSummary page 5…Device Type: Prescription Digital Therapeutic Device Manufacturer: Otsuka America Pharmaceutical, Inc. Premarket Notification Number: K231209 Device Classification: 21 CFR 882.5801, Computerized Behavioral Therapy Device for Psychiatric… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
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. 2026, 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?
Motivista (CT-155) is a prescription digital therapeutic indicated for the treatment of negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, in patients 18 years of age and older with clinically stable positive symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254038 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254038: Motivista (CT-155).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254038
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026