Theratronics, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Theratronics, Inc.” (first 1982, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 191 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 4 | 4 |
| IWB | System, Radiation Therapy, Radionuclide | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| IWD | Device, Beam Limiting, Teletherapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (8)
- Physical Medicine (1)
Most recent Theratronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983917 | THERATRON ELITE | IWB | 1998-12-04 | 30 |
| K970236 | THERAPLAN PLUS VERSION 1.2 | IYE | 1997-07-09 | 169 |
| K964606 | THERATRON 780E | IWB | 1997-06-26 | 220 |
| K964607 | THERATON 1000E | IWD | 1997-05-28 | 191 |
| K954679 | THERAPLAN PLUS | IYE | 1996-11-08 | 395 |
| K940237 | THERAPLAN V05B/ TP-11 V09B | IYE | 1994-07-26 | 189 |
| K922276 | THERAC 25 | IYE | 1994-05-25 | 740 |
| K894165 | THERATRON 1000 | IWB | 1990-02-01 | 230 |
| K820782 | THERATRONIC STIMULATOR | IPF | 1982-06-03 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Theratronics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Theratronics, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Theratronics, Inc.” (first 1982, latest 1998), across 4 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 Theratronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theratronics, Inc. is 191 days.
Which FDA product codes appear under Theratronics, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 4); IWB (System, Radiation Therapy, Radionuclide, 3); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 9 Theratronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Theratronics, 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.