Vermillion, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Vermillion, Inc.” (first 2016, latest 2016), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 375 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 375 |
| 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 |
|---|---|---|---|
| ONX | Ovarian Adnexal Mass Assessment Score Test System | 2 | 1 |
Review panels
- Immunology (2)
Most recent Vermillion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150588 | OVA1 Next Generation | ONX | 2016-03-18 | 375 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN090004 | De Novo | Ovarian Adnexal Mass Assessment Score Test System | 2009-09-11 |
Recalls
openFDA lists no recalls under a recalling firm named Vermillion, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vermillion, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Vermillion, Inc.” (first 2016, latest 2016), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vermillion, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vermillion, Inc. is 375 days.
Which FDA product codes appear under Vermillion, Inc.?
The most frequent FDA product codes under this applicant name are ONX (Ovarian Adnexal Mass Assessment Score Test System, 2).
Next steps
- See all 1 Vermillion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ONX, Vermillion, 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.