510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K233496Substantially Equivalent

EndeavorOTC

Akili Interactive Labs, Inc., Boston, MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233496 is the FDA 510(k) clearance record for EndeavorOTC, 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 K233496.

Clearance record

Decision date
Received
(228 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., 5th Floor, Boston, MA
510(k) summary
Summary PDF
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