# K243729: Prismira

- Pathway: 510(k) (Traditional)
- Applicant: Lumos Labs, Inc.
- Decided: Jun 13, 2025 after 192 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
Prismira is a digital therapeutic indicated to improve attention function in adults ages 22-55 years old with primarily inattentive or combined-type Attention Deficit and Hyperactivity Disorder (ADHD). Patients who engage with Prismira demonstrate improvements in a digitally assessed measure of sustained and selective attention, Test of Variables of Attention (TOVA), and may not display benefits in typical behavioral symptoms, such as hyperactivity. Prismira 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/K243729
Methodology: https://510kreport.com/methodology