Beta Bionics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Beta Bionics, Inc.” (first 2023, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 98 days, against 97 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 4 | 104 |
| 2024 | 0 | — |
| 2025 | 1 | 27 |
| 2026 | 3 | 139 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Beta Bionics, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 5 | 5 |
| QJI | Interoperable Automated Glycemic Controller | 3 | 3 |
Review panels
Most recent Beta Bionics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262763 | iLet Dosing Decision Software | QJI | 2026-09-11 | 38 |
| K260001 | Mint ACE Pump | QFG | 2026-09-11 | 252 |
| K253976 | iLet ACE Pump | QFG | 2026-04-30 | 139 |
| K252770 | iLet ACE Pump | QFG | 2025-09-29 | 27 |
| K232224 | iLet® Dosing Decision Software | QJI | 2023-09-22 | 57 |
| K231485 | iLet® ACE Pump | QFG | 2023-06-21 | 29 |
| K223846 | iLet® ACE Pump | QFG | 2023-05-19 | 150 |
| K220916 | iLet® Dosing Decision Software | QJI | 2023-05-19 | 415 |
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2026-03-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Beta Bionics, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06891898: The iLet Experience Study (Recruiting, started 2024-05-01)
SEC filings
Beta Bionics, Inc. (BBNX): EDGAR filings, CIK 1674632. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Beta Bionics, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Beta Medical Products Co. (3 510(k)s)
- Beta Biomed Services, Inc. (2 510(k)s)
- Beta Chemicals, Inc. (1 510(k)s)
- Beta Healthcare Products Pvt., Ltd. (1 510(k)s)
- Beta Labs, Inc. (1 510(k)s)
- Beta Med Pharmaceuticals, Inc. (1 510(k)s)
- Beta Optical Co, Inc. (1 510(k)s)
- Beta Toys, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Beta Bionics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Beta Bionics, Inc.” (first 2023, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Beta Bionics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beta Bionics, Inc. is 98 days. Since 2017: 98 days, versus 97 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Beta Bionics, Inc.?
The most frequent FDA product codes under this applicant name are QFG (Alternate Controller Enabled Insulin Infusion Pump, 5); QJI (Interoperable Automated Glycemic Controller, 3).
Next steps
- See all 8 Beta Bionics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QFG, Beta Bionics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.