# DEN220058: BT-001

- Pathway: De Novo (Direct)
- Applicant: Better Therapeutics
- Decided: Jul 7, 2023 after 289 days
- Product code: QXC (Diabetes Digital Therapeutic Device)
- Device class: 2
- Regulation: 21 CFR 880.5735
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.

Source page: https://510kreport.com/device/DEN220058
Methodology: https://510kreport.com/methodology