Osprey Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Osprey Medical, Inc.” (first 2013, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 97 days. Since 2017 the median was 64 days, against 154 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 |
|---|---|---|
| 2013 | 1 | 85 |
| 2014 | 2 | 123 |
| 2015 | 4 | 74 |
| 2016 | 2 | 80 |
| 2017 | 3 | 30 |
| 2018 | 2 | 62 |
| 2019 | 1 | 268 |
| 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 Osprey Medical, Inc. took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 15 | 15 |
Review panels
- General Hospital (15)
Most recent Osprey Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190102 | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System | DXT | 2019-10-17 | 268 |
| K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System | DXT | 2018-12-20 | 27 |
| K181936 | DyeVert PLUS EZ Contrast Reduction System | DXT | 2018-10-25 | 98 |
| K171698 | Smart Syringe | DXT | 2017-07-07 | 29 |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | DXT | 2017-05-26 | 30 |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | DXT | 2017-03-08 | 127 |
| K161505 | DyeVert NG Contrast Modulation System | DXT | 2016-08-03 | 63 |
| K153141 | DyeVert Contrast Modulation System | DXT | 2016-02-04 | 97 |
| K151300 | AVERT Contrast Modulation System | DXT | 2015-10-15 | 153 |
| K151746 | Dyevert Contrast Modulation System | DXT | 2015-10-09 | 102 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osprey 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.
Device clinical trials
An industry sponsor named Osprey Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03715452: DyeVert™ Plus Contrast Reduction System Multicenter Observational Study (Completed, started 2017-07-01)
- NCT02752802: DyeVert System RCT (Completed, started 2016-04)
- NCT02606734: DyeVert Pilot Trial (Completed, started 2015-10)
- NCT01976299: AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN (Completed, started 2013-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osprey Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Osprey Medical, Inc.” (first 2013, latest 2019), 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 Osprey Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osprey Medical, Inc. is 97 days. Since 2017: 64 days, versus 154 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osprey Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 15).
Next steps
- See all 15 Osprey Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Osprey 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.