Click Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Click Therapeutics, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 226 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 226 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Click Therapeutics, Inc. took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 338 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SAP | Computerized Behavioral Therapy Device For Depressive Disorders. | 1 | 1 |
| SEE | Computerized Behavioral Therapy Device For Migraine | 1 | 0 |
Review panels
- Neurology (2)
Most recent Click Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254038 | Motivista (CT-155) | SAP | 2026-07-30 | 226 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240064 | De Novo | Computerized Behavioral Therapy Device For Migraine | 2025-04-11 |
Recalls
openFDA lists no recalls under a recalling firm named Click Therapeutics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Click Therapeutics, Inc. is the lead sponsor of 13 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06486948: An Exploratory, Double-arm, 8-week Study to Explore the Feasibility and Acceptability of Abbreviated Treatment with CT-156 in People with Schizophrenia. (Completed, started 2024-05-06)
- NCT06275659: An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis (Completed, started 2023-12-04)
- NCT06136923: An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer (Completed, started 2023-10-19)
- NCT06136936: A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia (Completed, started 2023-09-20)
- NCT06067984: An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia (Completed, started 2023-09-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Click Therapeutics, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Click Therapeutics, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Click Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Click Therapeutics, Inc. is 226 days.
Which FDA product codes appear under Click Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are SAP (Computerized Behavioral Therapy Device For Depressive Disorders., 1); SEE (Computerized Behavioral Therapy Device For Migraine, 1).
Next steps
- See all 1 Click Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SAP, Click Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.