Medical Device Manufacturer · US , Concord , MA

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

8 submissions · 8 cleared · Since 2023

Recent clearances: Mint ACE Pump, iLet Dosing Decision Software, iLet ACE Pump

Official Website
8
Total
8
Cleared
0
Denied

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

8 devices
1-8 of 8
Cleared Sep 11, 2026
Mint ACE Pump
K260001 · QFG
Chemistry · 252d
Cleared Sep 11, 2026
iLet Dosing Decision Software
K262763 · QJI
Chemistry · 38d
Cleared Apr 30, 2026
iLet ACE Pump
K253976 · QFG
Chemistry · 139d
Cleared CT Sep 29, 2025
iLet ACE Pump
K252770 · QFG
Chemistry · 27d
Cleared Sep 22, 2023
iLet® Dosing Decision Software
K232224 · QJI
Chemistry · 57d
Cleared Jun 21, 2023
iLet® ACE Pump
K231485 · QFG
Chemistry · 29d
Cleared May 19, 2023
iLet® Dosing Decision Software
K220916 · QJI
Chemistry · 415d
Cleared May 19, 2023
iLet® ACE Pump
K223846 · QFG
Chemistry · 150d
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