FDA product code SAP: Computerized Behavioral Therapy Device For Depressive Disorders.
SAP is the FDA product code for computerized behavioral therapy device for depressive disorders.. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under SAP, 3 in the last five years, from 3 different applicants. The average 510(k) review took 360 days (median 338); 327 days on average over the last three years.
Definition
The device is intended to provide computerized behavioral therapy to treat depressive disorders.
Classification
| Field | Value |
|---|---|
| Device name | Computerized Behavioral Therapy Device For Depressive Disorders. |
| Device class | Class II |
| Regulation | 21 CFR 882.5801 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for SAP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 428 |
| 2026 | 1 | 226 |
Compare with all 510(k) review times · Search every SAP clearance
Top SAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Click Therapeutics, Inc. | 1 | 2026-07-30 |
| Curio Digital Therapeutics, Inc. | 1 | 2024-04-22 |
| Otsuka America Pharmaceutical, Inc. | 1 | 2024-03-30 |
Most recent SAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254038 | Click Therapeutics, Inc. | Motivista (CT-155) | 2026-07-30 | 226 |
| K223515 | Curio Digital Therapeutics, Inc. | MamaLift Plus | 2024-04-22 | 517 |
| K231209 | Otsuka America Pharmaceutical, Inc. | Rejoyn | 2024-03-30 | 338 |
Recalls for SAP devices
openFDA lists no recalls for product code SAP.
Frequently asked questions
What is FDA product code SAP?
SAP is the FDA product code for computerized behavioral therapy device for depressive disorders.. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel.
What device class is SAP?
Class II, regulation 21 CFR 882.5801. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAP?
Across 3 cleared submissions the average was 360 days from receipt to decision (median 338).
Which companies have the most SAP clearances?
Click Therapeutics, Inc. (1); Curio Digital Therapeutics, Inc. (1); Otsuka America Pharmaceutical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAP
- Run a recall and safety report across every SAP manufacturer
- Watch product code SAP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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