Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beta Bionics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
415 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026-04-30 | 139 | 0 |
| K252770 | iLet ACE Pump | Beta Bionics, Inc. | 2025-09-29 | 27 | 2 |
| K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-09-22 | 57 | 1 |
| K231485 | iLet® ACE Pump | Beta Bionics, Inc. | 2023-06-21 | 29 | 1 |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-05-19 | 415 | 0 |
| K223846 | iLet® ACE Pump | Beta Bionics, Inc. | 2023-05-19 | 150 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda