Beta Bionics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: iLet ACE Pump, iLet ACE Pump, iLet® Dosing Decision Software
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Beta Bionics, Inc. Chemistry ✕
6 devices
Cleared
Apr 30, 2026
iLet ACE Pump
Chemistry
139d
Cleared
CT
Sep 29, 2025
iLet ACE Pump
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