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Beta Bionics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
6
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1996-2026Class IIiLet Bionic Pancreas, REF: BB1001March 12, 2026
Z-2513-2026Class IIiLet Bionic Pancreas, REF: BB1001September 23, 2025
Z-1809-2026Class IIiLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareAugust 13, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K253976iLet ACE PumpApril 30, 2026
K252770iLet ACE PumpSeptember 29, 2025
K232224iLet® Dosing Decision SoftwareSeptember 22, 2023
K231485iLet® ACE PumpJune 21, 2023
K220916iLet® Dosing Decision SoftwareMay 19, 2023
K223846iLet® ACE PumpMay 19, 2023