Opko Health, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Opko Health, Inc.” (first 2008, latest 2008), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 268 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 | 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 |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | 1 | 1 |
| QRF | Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer | 1 | 0 |
Review panels
- Immunology (1)
- Ophthalmic (1)
Most recent Opko Health, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080460 | SPECTRAL OCT/SLO | OBO | 2008-11-14 | 268 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190022 | PMA | 4Kscore Test | 2021-12-07 |
Recalls
openFDA lists no recalls under a recalling firm named Opko Health, 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 Opko Health, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04063644: Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients (Completed, started 2019-05-30)
- NCT03762408: Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis. (Completed, started 2017-12-15)
- NCT03874013: Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency (Completed, started 2017-12-07)
- NCT02968004: Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children (Completed, started 2016-12)
- NCT00834223: A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG) (Completed, started 2009-01)
SEC filings
OPKO HEALTH, INC. (OPK): EDGAR filings, CIK 944809. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Opko Instrumentation, Inc. (1 510(k)s)
- Opko Diagnostics, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Opko Health, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Opko Health, Inc.” (first 2008, latest 2008), plus 1 PMA decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Opko Health, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Opko Health, Inc. is 268 days.
Which FDA product codes appear under Opko Health, Inc.?
The most frequent FDA product codes under this applicant name are OBO (Tomography, Optical Coherence, 1); QRF (Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer, 1).
Next steps
- See all 1 Opko Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OBO, Opko Health, 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.