De Novo · Granted
GrantedEndeavorRx
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
Granted on Jun 15, 2020 as a new device type through De Novo after a 60-day review. 3 later devices descend from it.
- Decided
- Jun 15, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- QFT
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN200026 EndeavorRxAkili Interactive Labs, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243729 PrismiraLumos Labs, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233496 EndeavorOTCAkili Interactive Labs, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231337 EndeavorRxAkili Interactive Labs, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200026 | EndeavorRx | Akili Interactive Labs, Inc. | 2020 | — |
| +1 | K243729 | Prismira | Lumos Labs, Inc. | 2025 | — |
| +1 | K233496 | EndeavorOTC | Akili Interactive Labs, Inc. | 2024 | — |
| +1 | K231337 | EndeavorRx | Akili Interactive Labs, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K243729 (Lumos Labs, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2020, 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?
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use 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/DEN200026 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200026: EndeavorRx.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200026
Report an extraction error
Are you the manufacturer?
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