Beta Bionics, Inc.
FDA Regulatory Profile
Beta Bionics, Inc. has 3 FDA recalls, 2 inspections, 9 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-1996-2026 · Class II · Mar 12, 2026
- Latest inspection
- Oct 21, 2024 · NAI
- Latest 510(k)
- Oct 21, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 3 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1996-2026 | Class II | iLet Bionic Pancreas, REF: BB1001 | Mar 12, 2026 |
| Z-2513-2026 | Class II | iLet Bionic Pancreas, REF: BB1001 | Sep 23, 2025 |
| Z-1809-2026 | Class II | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software | Aug 13, 2025 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K263422 | Mint ACE Pump | Oct 21, 2026 |
| K262763 | iLet Dosing Decision Software | Sep 11, 2026 |
| K260001 | Mint ACE Pump | Sep 11, 2026 |
| K253976 | iLet ACE Pump | Apr 30, 2026 |
| K252770 | iLet ACE Pump | Sep 29, 2025 |
| K232224 | iLet® Dosing Decision Software | Sep 22, 2023 |
| K231485 | iLet® ACE Pump | Jun 21, 2023 |
| K223846 | iLet® ACE Pump | May 19, 2023 |
| K220916 | iLet® Dosing Decision Software | May 19, 2023 |