Omnitron Intl., Inc.: FDA clearances and approvals
Omnitron Intl., Inc. has 7 FDA 510(k) clearances (first 1988, latest 1992), across 3 product codes in 1 review panel. Median 510(k) review time: 115 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 4 | 4 |
| KXK | Source, Brachytherapy, Radionuclide | 2 | 2 |
| IWA | Source, Wire, Iridium, Radioactive | 1 | 1 |
Review panels
- Radiology (7)
Most recent Omnitron Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901615 | PULMOCATH INTRABRONCHIAL CATHETER | JAQ | 1992-11-27 | 966 |
| K923130 | IR-192 IMPLANT -- MODIFICATION | KXK | 1992-09-21 | 88 |
| K920431 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE | JAQ | 1992-05-29 | 116 |
| K913908 | OMNITRON GYN APPLICATOR SYSTEM | JAQ | 1992-03-06 | 189 |
| K915253 | IR-192 IMPLANT, MODIFICATION | IWA | 1992-02-27 | 101 |
| K911775 | OMNICATH IMPLANTED CATHETER AND DEPOT | KXK | 1991-05-08 | 37 |
| K881665 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR | JAQ | 1988-08-11 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Omnitron Intl., Inc..
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 Omnitron Intl., Inc. have?
Omnitron Intl., Inc. has 7 FDA 510(k) clearances (first 1988, latest 1992), across 3 product codes in 1 review panel.
How long does FDA take to clear Omnitron Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Omnitron Intl., Inc.'s cleared 510(k)s is 115 days.
What devices does Omnitron Intl., Inc. make?
Its most frequent FDA product codes are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 4); KXK (Source, Brachytherapy, Radionuclide, 2); IWA (Source, Wire, Iridium, Radioactive, 1).
Has Omnitron Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Omnitron Intl., Inc. Related entities may recall under other names.
Next steps
- See all 7 Omnitron Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Omnitron Intl., Inc.'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.