QXC · Class II · 21 CFR 880.5735

FDA Product Code QXC: Diabetes Digital Therapeutic Device

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 With Diabetes Mellitus By Assisting Them In Managing Their Condition. This Device Is Not Intended To Replace Any Primary Treatment, Such As Diet/lifestyle Changes Or Medication.

Leading manufacturers include Better Therapeutics.

1
Total
0
Cleared
289d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Diabetes Digital Therapeutic Device Devices (Product Code QXC)

1 devices
1–1 of 1
Not Cleared Jul 07, 2023
BT-001
DEN220058
Better Therapeutics
Chemistry · 289d

About Product Code QXC - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXC since 2023, with 0 receiving FDA clearance (average review time: 289 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →