FDA Product Code QFT: Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment.
Leading manufacturers include Akili Interactive Labs, Inc. and Lumos Labs, Inc..
4
Total
3
Cleared
175d
Avg days
2020
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
192d avg (recent)
FDA 510(k) Cleared Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder Devices (Product Code QFT)
4 devices
Cleared
Jun 13, 2025
Prismira
Lumos Labs, Inc.
Neurology
192d
Cleared
Jun 14, 2024
EndeavorOTC
Akili Interactive Labs, Inc.
Neurology
228d
Cleared
Dec 13, 2023
EndeavorRx
Akili Interactive Labs, Inc.
Neurology
219d
Not Cleared
Jun 15, 2020
EndeavorRx
Akili Interactive Labs, Inc.
Neurology
60d
About Product Code QFT - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QFT since 2020, with 3 receiving FDA clearance (average review time: 175 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 - QFT Product Code
FDA review times for QFT submissions have been consistent, averaging 192 days recently vs 169 days historically.
QFT devices are reviewed by the Neurology panel. Browse all Neurology devices →