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Beta Bionics, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2026-04-30

SEC Filings: 1 filings on record. Latest: 10-Q (2026-07-29). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K253976 iLet ACE PumpQFG2026-04-30 View
510(k) K252770 iLet ACE PumpQFG2025-09-29 View
510(k) K232224 iLet® Dosing Decision SoftwareQJI2023-09-22 View
510(k) K231485 iLet® ACE PumpQFG2023-06-21 View
510(k) K223846 iLet® ACE PumpQFG2023-05-19 View
510(k) K220916 iLet® Dosing Decision SoftwareQJI2023-05-19 View
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