# K233496: EndeavorOTC

- Pathway: 510(k) (Traditional)
- Applicant: Akili Interactive Labs, Inc.
- Decided: Jun 14, 2024 after 228 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
Longest line of descent: 1 generation back to DEN200026 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200026: EndeavorRx, Akili Interactive Labs, Inc. (2020) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K233496
Methodology: https://510kreport.com/methodology