Not Cleared Direct

DEN220058 - BT-001 (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220058 · Better Therapeutics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
289d
Days
Class 2
Risk

DEN220058 is an FDA 510(k) submission (not cleared) for the BT-001. Classified as Diabetes Digital Therapeutic Device (product code QXC), Class II - Special Controls.

Submitted by Better Therapeutics (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on July 7, 2023 after a review of 289 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5735 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 289 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Better Therapeutics devices

Submission Details

510(k) Number DEN220058 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 21, 2022
Decision Date July 07, 2023
Days to Decision 289 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 88d · This submission: 289d
Pathway characteristics

Device Classification

Product Code QXC Diabetes Digital Therapeutic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5735
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.