Beta Bionics, Inc.
Medical device manufacturer in Irvine, CA.
8510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262763 | iLet Dosing Decision SoftwareQJI · Traditional | 09/11/2026SE |
| K260001 | Mint ACE PumpQFG · Traditional | 09/11/2026SE |
| K253976 | iLet ACE PumpQFG · Traditional | 04/30/2026SE |
| K252770 | iLet ACE PumpQFG · Special | 09/29/2025SE |
| K232224 | iLet® Dosing Decision SoftwareQJI · Traditional | 09/22/2023SE |
| K231485 | iLet® ACE PumpQFG · Special | 06/21/2023SE |
| K223846 | iLet® ACE PumpQFG · Traditional | 05/19/2023SE |
| K220916 | iLet® Dosing Decision SoftwareQJI · Traditional | 05/19/2023SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1996-2026 Class II | iLet Bionic Pancreas, REF: BB1001insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7… | 03/12/2026Open, Classified |
| Z-2513-2026 Class II | iLet Bionic Pancreas, REF: BB1001The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous… | 09/23/2025Open, Classified |
| Z-1809-2026 Class II | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Softwareit was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on… | 08/13/2025Open, Classified |