# DEN200026: EndeavorRx

- Pathway: De Novo (Direct)
- Applicant: Akili Interactive Labs, Inc.
- Decided: Jun 15, 2020 after 60 days
- Product code: QFT (Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder)
- Device class: 2
- Regulation: 21 CFR 882.5803
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243729: Prismira (2025), 0 descendants of its own
- K233496: EndeavorOTC (2024), 0 descendants of its own
- K231337: EndeavorRx (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN200026
Methodology: https://510kreport.com/methodology