Bruin Biometrics, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Bruin Biometrics, LLC”, 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 |
|---|---|---|---|
| QEF | Pressure Ulcer Management Tool | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170021 | De Novo | Pressure Ulcer Management Tool | 2018-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Bruin Biometrics, LLC.
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 Bruin Biometrics, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02701101: Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study (Completed, started 2016-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bruin Biometrics, LLC?
FDA lists 0 510(k) clearances under the applicant name “Bruin Biometrics, LLC”, 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 Bruin Biometrics, LLC?
The most frequent FDA product codes under this applicant name are QEF (Pressure Ulcer Management Tool, 1).
Next steps
- See all 0 Bruin Biometrics, LLC clearances with predicates and recalls
- Run predicate analysis for product code QEF, Bruin Biometrics, LLC'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.