Proteus Biomedical, Inc.: FDA clearances and approvals
Proteus Biomedical, Inc. has 1 FDA 510(k) clearance (first 2010, latest 2010), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 91 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| OZW | Ingestible Event Marker | 1 | 0 |
Review panels
- Cardiovascular (2)
Most recent Proteus Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093976 | RAISIN PERSONAL MONITOR | DXH | 2010-03-25 | 91 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120011 | De Novo | Ingestible Event Marker | 2012-07-10 |
Recalls
openFDA lists no recalls under a recalling firm named Proteus Biomedical, 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 Proteus Biomedical, Inc. have?
Proteus Biomedical, Inc. has 1 FDA 510(k) clearance (first 2010, latest 2010), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Proteus Biomedical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Proteus Biomedical, Inc.'s cleared 510(k)s is 91 days.
What devices does Proteus Biomedical, Inc. make?
Its most frequent FDA product codes are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1); OZW (Ingestible Event Marker, 1).
Has Proteus Biomedical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Proteus Biomedical, Inc. Related entities may recall under other names.
Next steps
- See all 1 Proteus Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Proteus Biomedical, 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.