Medical Device Manufacturer · US , Concord , MA

Beta Bionics, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2023

Total

Cleared

Denied

Beta Bionics, Inc. develops automated insulin delivery systems for type 1 diabetes management. The company is dedicated to simplifying diabetes care through innovative technology. Beta Bionics operates with a manufacturing facility in Concord, US.

The company has received 6 FDA 510(k) clearances from 6 total submissions since its first clearance in 2023. All submissions focus on Chemistry devices. The latest clearance occurred in 2026, confirming the company remains actively engaged in regulatory submissions.

Beta Bionics specializes in Chemistry devices, including the iLet Bionic Pancreas system and its associated dosing decision software. These products automatically adjust insulin delivery based on continuous glucose monitoring data. The company was founded in 2015 and has conducted over 12 years of clinical research supporting its technology platform.

Explore the company's complete FDA 510(k) clearance history, device names, product codes, and clearance dates in the database.

1 device has linked clinical trial registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Beta Bionics, Inc.

6 devices

1-6 of 6

Cleared CT Sep 29, 2025