# Beta Bionics, Inc.

- Location (FDA's records): Concord, MA
- FDA decisions: 9 (2023–2026): 9 510(k) clearances
- Product codes: QFG (6), QJI (3)
- 510(k) review time since 2016: median 57 days, against 103 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tandem Diabetes Care, Inc.: 2 (https://510kreport.com/company/tandem-diabetes-care)
- Insulet Corporation: 1 (https://510kreport.com/company/insulet)

## Its most-cited devices
- K220916: iLet® Dosing Decision Software (2023), cited by 1
- K223846: iLet® ACE Pump (2023), cited by 1
- K232224: iLet® Dosing Decision Software (2023), cited by 1
- K231485: iLet® ACE Pump (2023), cited by 1
- K252770: iLet ACE Pump (2025), cited by 1

## Recent decisions
- 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)
- K220916: iLet® Dosing Decision Software (May 19, 2023)

Source page: https://510kreport.com/company/beta-bionics