510(k) · Cleared
ClearedEndeavorOTC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akili Interactive Labs, Inc. · QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Cleared on Jun 14, 2024 as substantially equivalent to DEN200026 (Akili Interactive Labs, Inc., 2020) after a 228-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jun 14, 2024
- Review
- 228 days
- Class
- Class II
- Product code
- QFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200026 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200026 EndeavorRxAkili Interactive Labs, Inc. · 2020
- This deviceK233496 EndeavorOTCAkili Interactive Labs, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200026 | EndeavorRx | Akili Interactive Labs, Inc. | 2020 | — |
| 0 (this device) | K233496 | EndeavorOTC | Akili Interactive Labs, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFT device
- #1 K243729 Prismirascore 9.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN200026.
How does its category compare?
All QFT devicesQFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QFT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFT
Too few QFT 510(k)s in any year since 2007 to give a median.
Recalls per year · QFT
No recall names QFT since 2007.
Adverse event reports per year · QFT
2in 2023
MAUDE reports naming product code QFT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EndeavorOTC is a digital therapeutic indicated to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorOTC demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral…
Read the full statement (107 words)
EndeavorOTC is a digital therapeutic indicated to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorOTC demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral symptoms such as hyperactivity. EndeavorOTC is not intended to be a replacement for any form of treatment and should be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233496: EndeavorOTC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233496
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026