Radiadyne: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Radiadyne” (first 2009, latest 2017), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 100 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 | 1 | 78 |
| 2015 | 1 | 89 |
| 2016 | 0 | — |
| 2017 | 1 | 220 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Radiadyne took a median 220 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NZT | Dosimeter, Ionizing Radiation, Implanted | 3 | 3 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 | 1 |
| PCT | Prostate Immobilizer Rectal Balloon | 1 | 0 |
Review panels
- Radiology (5)
Most recent Radiadyne 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | NZT | 2017-06-01 | 220 |
| K150719 | OARtrac System with Skin Sensors | NZT | 2015-06-16 | 89 |
| K141154 | OARTRAC SYSTEM | NZT | 2014-07-22 | 78 |
| K092534 | ALATUS VAGINAL BALLOON PACKING SYSTEM | JAQ | 2009-12-07 | 110 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130036 | De Novo | Prostate Immobilizer Rectal Balloon | 2014-01-28 |
Recalls
openFDA lists no recalls under a recalling firm named Radiadyne.
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.
- Radiadyne, LLC (Specification Developer) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiadyne?
FDA lists 4 510(k) clearances under the applicant name “Radiadyne” (first 2009, latest 2017), plus 1 De Novo decision, 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 Radiadyne?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiadyne is 100 days.
Which FDA product codes appear under Radiadyne?
The most frequent FDA product codes under this applicant name are NZT (Dosimeter, Ionizing Radiation, Implanted, 3); JAQ (System, Applicator, Radionuclide, Remote-Controlled, 1); PCT (Prostate Immobilizer Rectal Balloon, 1).
Next steps
- See all 4 Radiadyne clearances with predicates and recalls
- Run predicate analysis for product code NZT, Radiadyne'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.