Theragenics Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Theragenics Corp.” (first 1987, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 4 | 4 |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | 1 | 1 |
Review panels
- Radiology (5)
Most recent Theragenics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103319 | I-SEED | KXK | 2011-01-03 | 52 |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | KXK | 2007-09-26 | 40 |
| K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | KXK | 2005-01-26 | 28 |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | KXK | 2001-04-26 | 86 |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | IWI | 1987-12-22 | 29 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-10-09.
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 Theragenics Corp.?
FDA lists 5 510(k) clearances under the applicant name “Theragenics Corp.” (first 1987, latest 2011), across 2 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 Theragenics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theragenics Corp. is 40 days.
Which FDA product codes appear under Theragenics Corp.?
The most frequent FDA product codes under this applicant name are KXK (Source, Brachytherapy, Radionuclide, 4); IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum, 1).
Next steps
- See all 5 Theragenics Corp. clearances with predicates and recalls
- Run predicate analysis for product code KXK, Theragenics 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.