510(k) Report

FDA applicant

Akili Interactive Labs, Inc.

Boston,, MA3 decisions2020–20240 recalls

FDA records 3 decisions for Akili Interactive Labs, Inc. (Boston,, MA) from 2020 to 2024: 2 510(k) clearances and 1 De Novo grant. All are in product code QFT (Digital Therapeutic Software For Attention…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Akili Interactive Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12023: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Akili Interactive Labs, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Akili Interactive Labs, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder3decisions

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN200026EndeavorRxAkili Interactive Labs, Inc. · 20203cite it

What has FDA decided for it lately?

  • K233496EndeavorOTCAkili Interactive Labs, Inc. · 2024
  • K231337EndeavorRxAkili Interactive Labs, Inc. · 2023
  • DEN200026EndeavorRxAkili Interactive Labs, Inc. · 2020

All 3 as Akili Interactive Labs, Inc. →