Better Therapeutics: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Better Therapeutics”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QXC | Diabetes Digital Therapeutic Device | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220058 | De Novo | Diabetes Digital Therapeutic Device | 2023-07-07 |
Recalls
openFDA lists no recalls under a recalling firm named Better Therapeutics.
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 Better Therapeutics is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05357248: Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH (Completed, started 2022-04-10)
- NCT04886388: Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes (Completed, started 2021-04-22)
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.
- Better Care Plastic Technology Co., Ltd. (11 510(k)s)
- Better Water, Inc. (4 510(k)s)
- Better Care Plastic Technology Cp., Ltd. (2 510(k)s)
- Better Diagnostics AI Corp. (2 510(k)s)
- Better Hearing, Inc. (2 510(k)s)
- Better Care S.L. (1 510(k)s)
- Better Health Medical Products Co., Ltd. (1 510(k)s)
- Better Life Medical Technologies, Inc. (1 510(k)s)
- Better Plastic Co., Ltd. (1 510(k)s)
- Better Water, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Better Therapeutics?
FDA lists 0 510(k) clearances under the applicant name “Better Therapeutics”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Better Therapeutics?
The most frequent FDA product codes under this applicant name are QXC (Diabetes Digital Therapeutic Device, 1).
Next steps
- See all 0 Better Therapeutics clearances with predicates and recalls
- Run predicate analysis for product code QXC, Better Therapeutics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.