Ohio Nuclear, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ohio Nuclear, Inc.” (first 1977, latest 1980), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 26 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
Review panels
- Radiology (7)
Most recent Ohio Nuclear, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792603 | COMPUTED TOMOGRAPHY X-RAY SCANNER | JAK | 1980-01-28 | 41 |
| K791195 | DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN | JAK | 1979-07-30 | 34 |
| K781079 | SONOGRAF ULTRASOUND B-SCANNING SYSTEM | IYO | 1978-07-17 | 19 |
| K780165 | PROCESSOR, VIDEO IMAGE VIP-550 | IYX | 1978-03-02 | 30 |
| K780115 | SCANNERS, TOMOGRAPHIC, COMPUTED | JAK | 1978-01-30 | 11 |
| K772305 | RAD. THERAPY PLANNING SUP. SYS. | JAK | 1978-01-09 | 26 |
| K771082 | DELTASCAN 2000 SERIES | JAK | 1977-06-24 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Ohio Nuclear, 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.
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.
- Ohio Medical Products (47 510(k)s)
- Ohio Medical Instrument Co., Inc. (19 510(k)s)
- Ohio Imaging, Inc. (3 510(k)s)
- Ohio Medical Corporation (2 510(k)s)
- Ohio Health Care Products, Inc. (1 510(k)s)
- Ohio Medical Research, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ohio Nuclear, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Ohio Nuclear, Inc.” (first 1977, latest 1980), across 3 product codes 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 Ohio Nuclear, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ohio Nuclear, Inc. is 26 days.
Which FDA product codes appear under Ohio Nuclear, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 5); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1); IYX (Camera, Scintillation (Gamma), 1).
Next steps
- See all 7 Ohio Nuclear, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Ohio Nuclear, 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.