Akili Interactive Labs, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Akili Interactive Labs, Inc.” (first 2023, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 224 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 219 |
| 2024 | 1 | 228 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Akili Interactive Labs, Inc. took a median 224 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 219 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFT | Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder | 3 | 2 |
Review panels
- Neurology (3)
Most recent Akili Interactive Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233496 | EndeavorOTC | QFT | 2024-06-14 | 228 |
| K231337 | EndeavorRx | QFT | 2023-12-13 | 219 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200026 | De Novo | Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder | 2020-06-15 |
Recalls
openFDA lists no recalls under a recalling firm named Akili Interactive Labs, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Akili Interactive Labs, Inc. is the lead sponsor of 10 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06376032: EndeavorOTC® Research Study in College Students (Active not recruiting, started 2024-01-10)
- NCT06109051: EndeavorOTC™ Prospective Product Registry (Active not recruiting, started 2023-10-03)
- NCT05991167: EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx") (Active not recruiting, started 2022-06-01)
- NCT04897074: Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents) (Completed, started 2021-06-29)
- NCT03844269: Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01 (Completed, started 2019-05-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Akili Interactive Labs, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Akili Interactive Labs, Inc.” (first 2023, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Akili Interactive Labs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Akili Interactive Labs, Inc. is 224 days.
Which FDA product codes appear under Akili Interactive Labs, Inc.?
The most frequent FDA product codes under this applicant name are QFT (Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder, 3).
Next steps
- See all 2 Akili Interactive Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QFT, Akili Interactive Labs, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.