Medical Device Manufacturer · US , Concord , MA

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

5 submissions · 5 cleared · Since 2023

5

Total

5

Cleared

0

Denied

FDA 510(k) cleared devices by Beta Bionics, Inc. Chemistry ✕

5 devices

1-5 of 5

Cleared Sep 29, 2025

Chemistry · 27d

Cleared Sep 22, 2023

iLet® Dosing Decision Software

Chemistry · 57d

Cleared Jun 21, 2023

iLet® ACE Pump

Chemistry · 29d

Cleared May 19, 2023

iLet® Dosing Decision Software

Chemistry · 415d

Cleared May 19, 2023

iLet® ACE Pump

Chemistry · 150d