510(k) · Cleared
ClearedPrismira
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumos Labs, Inc. · QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Cleared on Jun 13, 2025 as substantially equivalent to DEN200026 (Akili Interactive Labs, Inc., 2020) after a 192-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jun 13, 2025
- Review
- 192 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 deviceK243729 PrismiraLumos Labs, Inc. · 2025
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) | K243729 | Prismira | Lumos Labs, Inc. | 2025 | — |
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 K233496 EndeavorOTCscore 7.5 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200026 | EndeavorRxSummary page 5…510(k) Number K243729 Predicate Device Information Device Manufacturer: Akili Interactive Labs, Inc. Submission Number: DEN200026 Device Name: EndeavorRx Other Reference Devices: EndeavorRx (K231337), EndeavorOTC (K233496) Pr… | 2020 |
| † | K231337 | EndeavorRx | 2023 |
| † | K233496 | EndeavorOTC | 2024 |
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. 2025, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243729: Prismira.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243729
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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