FDA product code QFT: Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFT is the FDA product code for digital therapeutic software for attention deficit hyperactivity disorder. It is a Class II device, regulated under 21 CFR 882.5803 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under QFT, 3 in the last five years, from 2 different applicants. The average 510(k) review took 213 days (median 219); 210 days on average over the last three years. 1 De Novo request was granted under it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder |
| Device class | Class II |
| Regulation | 21 CFR 882.5803 |
| Review panel | NE — Neurology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for QFT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 219 |
| 2024 | 1 | 228 |
| 2025 | 1 | 192 |
Compare with all 510(k) review times · Search every QFT clearance
Top QFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akili Interactive Labs, Inc. | 2 | 2024-06-14 |
| Lumos Labs, Inc. | 1 | 2025-06-13 |
Most recent QFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243729 | Lumos Labs, Inc. | Prismira | 2025-06-13 | 192 |
| K233496 | Akili Interactive Labs, Inc. | EndeavorOTC | 2024-06-14 | 228 |
| K231337 | Akili Interactive Labs, Inc. | EndeavorRx | 2023-12-13 | 219 |
Recalls for QFT devices
openFDA lists no recalls for product code QFT.
Frequently asked questions
What is FDA product code QFT?
QFT is the FDA product code for digital therapeutic software for attention deficit hyperactivity disorder. It is a Class II device, regulated under 21 CFR 882.5803 and reviewed by the Neurology panel.
What device class is QFT?
Class II, regulation 21 CFR 882.5803. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFT?
Across 3 cleared submissions the average was 213 days from receipt to decision (median 219).
Which companies have the most QFT clearances?
Akili Interactive Labs, Inc. (2); Lumos Labs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QFT
- Run a recall and safety report across every QFT manufacturer
- Watch product code QFT 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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