Radiotherapeutics Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Radiotherapeutics Corp.” (first 1995, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 10 | 10 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| JOS | Electrode, Electrosurgical | 1 | 1 |
Review panels
Most recent Radiotherapeutics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011220 | LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE | GEI | 2002-07-01 | 437 |
| K012315 | LEVEEN ELECTRODE | GEI | 2001-10-11 | 80 |
| K000241 | RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR | GEI | 2000-04-14 | 78 |
| K982556 | LEVEEN NEEDLE ELECTRODE | GEI | 2000-04-06 | 624 |
| K000032 | LEVEEN NEEDLE ELECTRODE | GEI | 2000-03-30 | 85 |
| K982854 | MR COMPATIBLE LEVEEN NEEDLE ELECTRODE | GEI | 1998-11-10 | 89 |
| K981672 | RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR | GEI | 1998-07-17 | 66 |
| K972441 | RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 | GEI | 1997-09-04 | 66 |
| K962313 | MODIFIED LEVEEN NEEDLE ELECTRODE | JOS | 1996-09-11 | 86 |
| K962386 | SENSOR SHEATH TS1 | FLL | 1996-08-20 | 61 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radiotherapeutics Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiotherapeutics Corp.?
FDA lists 12 510(k) clearances under the applicant name “Radiotherapeutics Corp.” (first 1995, latest 2002), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radiotherapeutics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiotherapeutics Corp. is 82 days.
Which FDA product codes appear under Radiotherapeutics Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 10); FLL (Continuous Measurement Thermometer, 1); JOS (Electrode, Electrosurgical, 1).
Next steps
- See all 12 Radiotherapeutics Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Radiotherapeutics Corp.'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.