510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220058Unknown

Bt-001

Better Therapeutics, San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220058 is the FDA 510(k) clearance record for BT-001, a class II device, cleared for Better Therapeutics on under FDA product code QXC (Diabetes Digital Therapeutic Device). FDA's definition for product code QXC reads: "A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients...". FDA records list one 510(k) clearance for Better Therapeutics. As of , FDA records show no recalls naming DEN220058.

Clearance record

Decision date
Received
(289 days to decision)
Product code
QXC Diabetes Digital Therapeutic Device
Regulation
21 CFR 880.5735
Device class
Class II
Review panel
General Hospital
Applicant
Better Therapeutics 548 Market St. #49404, San Francisco CA
Third party review
No

Clearances, product code QXC

Trailing 12 months

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

FDA records show no clearances under product code QXC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXC, 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