Radiation Products Design, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Radiation Products Design, Inc.” (first 1979, latest 2015), across 3 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 | 1 | 210 |
| 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 | 6 | 6 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (7)
Most recent Radiation Products Design, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150382 | Radio Therapy Treatment Chair | IYE | 2015-09-16 | 210 |
| K800760 | BITE BLOCK SYSTEM | — | 1980-05-28 | 54 |
| K800792 | ADJUSTABLE HEAD & FACE HOLDER | IYE | 1980-05-14 | 36 |
| K800791 | MYLAR WINDOW-TABLE INSERT PANEL | IYE | 1980-05-14 | 36 |
| K800790 | TENNIS RACKET-TABLE INSERT PANEL | IYE | 1980-05-14 | 36 |
| K800761 | POINT TO POINT LEVEL | IYE | 1980-05-14 | 40 |
| K800759 | ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER | IYE | 1980-05-14 | 40 |
| K791178 | MYVACET 5-07, 7-00 AND 9-40 | IXI | 1979-09-17 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Radiation Products Design, 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.
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.
- Radiation Measurements, Inc. (12 510(k)s)
- Radiation Technology, Inc. (7 510(k)s)
- Radiation Development Co., Inc. (2 510(k)s)
- Radiation Monitoring Devices, Inc. (2 510(k)s)
- Radiation Oncology Computer Systems (2 510(k)s)
- Radiation Safety & Nuclear Products, Inc. (2 510(k)s)
- Radiation Products, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiation Products Design, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Radiation Products Design, Inc.” (first 1979, latest 2015), 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 Radiation Products Design, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiation Products Design, Inc. is 40 days.
Which FDA product codes appear under Radiation Products Design, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 6); IXI (Block, Beam-Shaping, Radiation Therapy, 1).
Next steps
- See all 8 Radiation Products Design, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Radiation Products Design, 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.