Company · US
Beta Bionics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (4 in 12 months)
3recalls (3 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K263422 | Mint ACE Pump Beta Bionics, Inc. | QFG |
| Sep 11, 2026 | K262763 | iLet Dosing Decision Software Beta Bionics, Inc. | QJI |
| Sep 11, 2026 | K260001 | Mint ACE Pump Beta Bionics, Inc. | QFG |
| Apr 30, 2026 | K253976 | iLet ACE Pump Beta Bionics, Inc. | QFG |
| Sep 29, 2025 | K252770 | iLet ACE Pump Beta Bionics, Inc. | QFG |
| Sep 22, 2023 | K232224 | iLet® Dosing Decision Software Beta Bionics, Inc. | QJI |
| Jun 21, 2023 | K231485 | iLet® ACE Pump Beta Bionics, Inc. | QFG |
| May 19, 2023 | K223846 | iLet® ACE Pump Beta Bionics, Inc. | QFG |
| May 19, 2023 | K220916 | iLet® Dosing Decision Software Beta Bionics, Inc. | QJI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 Open, Classified |
QFG | K252770 |
| Apr 29, 2026 | Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 Open, Classified |
QFG | K252770 |
| Apr 10, 2026 | Beta Bionics, Inc. iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software Open, Classified |
QFG | K231485 K232224 |