Roxwood Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Roxwood Medical, Inc.” (first 2012, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 126 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 |
|---|---|---|
| 2012 | 1 | 165 |
| 2013 | 0 | — |
| 2014 | 1 | 224 |
| 2015 | 2 | 75 |
| 2016 | 3 | 149 |
| 2017 | 1 | 26 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Roxwood Medical, Inc. took a median 26 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 8 | 8 |
Review panels
- Cardiovascular (8)
Most recent Roxwood Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170403 | CenterCross Ultra LV Catheter | DQY | 2017-03-07 | 26 |
| K160681 | CenterCross Ultra Catheter | DQY | 2016-06-17 | 99 |
| K152957 | MultiCross Catheter | DQY | 2016-03-04 | 149 |
| K152456 | CenterCross Ultra Catheter | DQY | 2016-01-26 | 151 |
| K151082 | MicroCross Catheter | DQY | 2015-06-07 | 46 |
| K143744 | MicroCross Catheter | DQY | 2015-04-14 | 104 |
| K140910 | CENTERCROSS CATHETER | DQY | 2014-11-19 | 224 |
| K121763 | MULTICROSS SUPPORT CATHETER | DQY | 2012-11-27 | 165 |
Recalls
openFDA lists no recalls under a recalling firm named Roxwood Medical, 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 Roxwood Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Roxwood Medical, Inc.” (first 2012, latest 2017), 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 Roxwood Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roxwood Medical, Inc. is 126 days.
Which FDA product codes appear under Roxwood Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 8).
Next steps
- See all 8 Roxwood Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Roxwood Medical, 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.