Clairity, Inc.: FDA clearances and approvals
Clairity, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SEZ | Radiological Software Device To Predict Future Breast Cancer Risk | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240047 | De Novo | Radiological Software Device To Predict Future Breast Cancer Risk | 2025-05-30 |
Recalls
openFDA lists no recalls under a recalling firm named Clairity, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Clairity, Inc. have?
Clairity, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Clairity, Inc. make?
Its most frequent FDA product codes are SEZ (Radiological Software Device To Predict Future Breast Cancer Risk, 1).
Has Clairity, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Clairity, Inc. Related entities may recall under other names.
Next steps
- See all 0 Clairity, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SEZ, Clairity, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.