DeviceClearance

Product code QXC— General Hospital

BT-001

Classification name
Diabetes Digital Therapeutic Device
Device class
Class 2
Regulation
21 CFR 880.5735
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QXC under 21 CFR 880.5735, via openFDA

Market context for product code QXC

FDA has cleared 1 device under product code QXC, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXC

Recent clearances under product code QXC

Data sourced from openFDA. This site is unofficial and independent of the FDA.