Cleared Traditional

K254038 - Motivista (CT-155)

K254038 is an FDA 510(k) clearance for Motivista (CT-155), manufactured by Click Therapeutics, Inc.. The device is a Class 2 Neurology device with product code SAP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K254038 · Click Therapeutics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
226d
Days
Class 2
Risk

K254038 is an FDA 510(k) clearance for the Motivista (CT-155). Classified as Computerized Behavioral Therapy Device For Depressive Disorders. (product code SAP), Class II - Special Controls.

Submitted by Click Therapeutics, Inc. (New York, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 226 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5801 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Click Therapeutics, Inc. devices

FDA 510(k) Submission Details - K254038

510(k) Number K254038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2025
Decision Date July 30, 2026
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 148d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

SAP Device Classification - Class 2, Special Controls

Product Code SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5801
Definition The Device Is Intended To Provide Computerized Behavioral Therapy To Treat Depressive Disorders.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05838625 Completed Interventional Industry-sponsored

Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia

A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia

464
Patients (actual)
54
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Schizophrenia
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Viveca Livezey, MD
Sponsor Click Therapeutics, Inc. (industry)
Started 2023-03-31 → Primary completion 2025-06-20 → Completed 2025-07-23
Primary outcome
Experiential negative symptoms
Secondary outcome
Motivation and pleasure symptoms
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov