Devoro Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Devoro Medical, Inc.” (first 2020, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 181 days. Since 2017 the median was 181 days, against 67 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2020 | 1 | 101 |
| 2021 | 2 | 194 |
| 2022 | 1 | 181 |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Devoro Medical, Inc. took a median 181 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 67 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Devoro Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241207 | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02) | QEW | 2024-05-29 | 29 |
| K221391 | WOLF Thrombectomy SmartClaw Catheter | QEW | 2022-11-10 | 181 |
| K210911 | WOLF Thrombectomy System, 14F | QEW | 2021-10-19 | 204 |
| K210530 | WOLF Thrombectomy System, 6F | QEW | 2021-08-27 | 184 |
| K200101 | WOLF Thrombectomy V System | QEW | 2020-04-27 | 101 |
Recalls
openFDA lists no recalls under a recalling firm named Devoro 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 Devoro Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Devoro Medical, Inc.” (first 2020, latest 2024), 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 Devoro Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devoro Medical, Inc. is 181 days. Since 2017: 181 days, versus 67 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Devoro Medical, Inc.?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 5).
Next steps
- See all 5 Devoro Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEW, Devoro 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.