Orion Corp.: FDA clearances and approvals
Orion Corp. has 21 FDA 510(k) clearances (first 1985, latest 1992), across 12 product codes in 4 review panels. Median 510(k) review time: 74 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 |
|---|---|---|---|
| LQN | Latex Agglutination Assay, Rubella | 4 | 4 |
| IZH | System, X-Ray, Mammographic | 3 | 3 |
| JSI | Culture Media, Selective And Differential | 3 | 3 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 2 |
| MSJ | Apolipoproteins | 2 | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 | 1 |
Plus 2 more product codes.
Review panels
- Microbiology (11)
- Radiology (4)
- Clinical Chemistry (3)
- Immunology (3)
Most recent Orion Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912391 | RUBALEX, MODIFICATION | LQN | 1992-05-04 | 346 |
| K901637 | RESUBMITTED MODIFIED RUBALEX | LQN | 1990-04-26 | 17 |
| K884650 | RESUBMITTED SCANORA | IZF | 1989-03-16 | 129 |
| K890199 | DENTOCULT SM-STRIP MUTANS | JSI | 1989-03-02 | 43 |
| K881506 | MAMEX DC MAG MG12 | IZH | 1988-06-10 | 60 |
| K881505 | MAMEX DC MG11 | IZH | 1988-06-10 | 60 |
| K874040 | MAMEX DC S SL10/MG14 | IZH | 1987-11-23 | 49 |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | LJP | 1987-09-22 | 74 |
| K872301 | DENTOCULT-SM CULTURE-PADDLE | JSI | 1987-09-11 | 88 |
| K864457 | CHLAMYSET ANTIBODY EIA | LJC | 1987-09-11 | 303 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orion Corp..
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 Orion Corp. have?
Orion Corp. has 21 FDA 510(k) clearances (first 1985, latest 1992), across 12 product codes in 4 review panels.
How long does FDA take to clear Orion Corp.'s 510(k)s?
The median time from FDA receipt to decision across Orion Corp.'s cleared 510(k)s is 74 days.
What devices does Orion Corp. make?
Its most frequent FDA product codes are LQN (Latex Agglutination Assay, Rubella, 4); IZH (System, X-Ray, Mammographic, 3); JSI (Culture Media, Selective And Differential, 3).
Has Orion Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Orion Corp. Related entities may recall under other names.
Next steps
- See all 21 Orion Corp. clearances with predicates and recalls
- Run predicate analysis for product code LQN, Orion Corp.'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.