FDA Product Code SAP: Computerized Behavioral Therapy Device For Depressive Disorders.
The Device Is Intended To Provide Computerized Behavioral Therapy To Treat Depressive Disorders.
Leading manufacturers include Curio Digital Therapeutics, Inc. and Otsuka America Pharmaceutical, Inc..
3
Total
3
Cleared
360d
Avg days
2024
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
226d
recently vs 428d historically
FDA 510(k) Cleared Computerized Behavioral Therapy Device For Depressive Disorders. Devices (Product Code SAP)
3 devices
Cleared
Apr 22, 2024
MamaLift Plus
Curio Digital Therapeutics, Inc.
Neurology
517d
Cleared
Mar 30, 2024
Rejoyn
Otsuka America Pharmaceutical, Inc.
Neurology
338d
About Product Code SAP - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SAP since 2024, with 3 receiving FDA clearance (average review time: 360 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - SAP Product Code
Recent submissions under SAP have taken an average of 226 days to reach a decision - down from 428 days historically, suggesting improved FDA processing for this classification.
SAP devices are reviewed by the Neurology panel. Browse all Neurology devices →