FDA product code SCP: Computerized Behavioral Therapy Device For Anxiety Disorders
SCP is the FDA product code for computerized behavioral therapy device for anxiety disorders. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SCP, 1 in the last five years. The average 510(k) review took 267 days (median 267); 267 days on average over the last three years.
Definition
Computerized behavioral therapy device for psychiatric disorders
Classification
| Field | Value |
|---|---|
| Device name | Computerized Behavioral Therapy Device For Anxiety 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 SCP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 267 |
Compare with all 510(k) review times · Search every SCP clearance
Top SCP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Big Health, Inc. | 1 | 2024-08-30 |
Most recent SCP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233872 | Big Health, Inc. | Daylight | 2024-08-30 | 267 |
Recalls for SCP devices
openFDA lists no recalls for product code SCP.
Frequently asked questions
What is FDA product code SCP?
SCP is the FDA product code for computerized behavioral therapy device for anxiety disorders. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel.
What device class is SCP?
Class II, regulation 21 CFR 882.5801. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCP?
Across 1 cleared submissions the average was 267 days from receipt to decision (median 267).
Which companies have the most SCP clearances?
Big Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCP
- Run a recall and safety report across every SCP manufacturer
- Watch product code SCP 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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