Cereve, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Cereve, Inc.”, 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 |
|---|---|---|---|
| PLU | Thermal System For Insomnia | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140032 | De Novo | Thermal System For Insomnia | 2016-05-13 |
Recalls
openFDA lists no recalls under a recalling firm named Cereve, Inc..
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 Cereve, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01882699: 30 Days in Home Use and Home Use Patterns Over 6 Months (Completed, started 2013-05)
- NCT01790256: Comparison of Two Temperatures to Treat Insomnia (Completed, started 2013-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cereve, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Cereve, Inc.”, 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 Cereve, Inc.?
The most frequent FDA product codes under this applicant name are PLU (Thermal System For Insomnia, 1).
Next steps
- See all 0 Cereve, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PLU, Cereve, 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.