# K254038: Motivista (CT-155)

- Pathway: 510(k) (Traditional)
- Applicant: Click Therapeutics, Inc.
- Decided: Jul 30, 2026 after 226 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: 2 generations back to DEN160018 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231209: Rejoyn, Otsuka America Pharmaceutical, Inc. (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K254038
Methodology: https://510kreport.com/methodology