Omnimedical: FDA clearances and approvals
Omnimedical has 6 FDA 510(k) clearances (first 1979, latest 1983), across 4 product codes in 2 review panels. Median 510(k) review time: 42 days.
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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| FMH | Container, Specimen, Sterile | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (4)
- General Hospital (1)
Most recent Omnimedical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K837378 | OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM | — | 1983-05-18 | 62 |
| K820180 | CALCULI FILTER CUP | FMH | 1982-02-05 | 14 |
| K812393 | 4001 CT SCANNER | JAK | 1981-10-13 | 54 |
| K812400 | OMNIMEDICAL QUAD I | JAK | 1981-10-02 | 43 |
| K802206 | OMNI SCANNER CT 6000 | JAK | 1980-10-23 | 42 |
| K790673 | OMNIMEDICAL AUTOMATIC 1001 | IZL | 1979-05-04 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Omnimedical.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Omnimedical have?
Omnimedical has 6 FDA 510(k) clearances (first 1979, latest 1983), across 4 product codes in 2 review panels.
How long does FDA take to clear Omnimedical's 510(k)s?
The median time from FDA receipt to decision across Omnimedical's cleared 510(k)s is 42 days.
What devices does Omnimedical make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 3); FMH (Container, Specimen, Sterile, 1); IZL (System, X-Ray, Mobile, 1).
Has Omnimedical had device recalls?
openFDA lists no recalls under a recalling firm name matching Omnimedical. Related entities may recall under other names.
Next steps
- See all 6 Omnimedical clearances with predicates and recalls
- Run predicate analysis for product code JAK, Omnimedical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.