510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200026Unknown

EndeavorRx

Akili Interactive Labs, Inc., Boston MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200026 is the FDA 510(k) clearance record for EndeavorRx, a class II device, cleared for Akili Interactive Labs, Inc. on under FDA product code QFT (Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder). FDA's definition for product code QFT reads: "A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment". FDA records list 3 510(k) clearances for Akili Interactive Labs, Inc., from to . As of , FDA records show no recalls naming DEN200026.

Clearance record

Decision date
Received
(60 days to decision)
Product code
QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Regulation
21 CFR 882.5803
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Akili Interactive Labs, Inc. 125 Broad St., 4th Floor, Boston MA
Third party review
No

Clearances, product code QFT

Trailing 12 months

FDA records hold no clearances under product code QFT in the trailing twelve months.

FDA records show no clearances under product code QFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260