Radiant Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Radiant Medical” (first 2002, latest 2007), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| NCX | System, Hypothermia, Intravenous, Cooling | 4 | 4 |
| DQY | Catheter, Percutaneous | 2 | 2 |
Review panels
- Neurology (4)
- Cardiovascular (2)
Most recent Radiant Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | NCX | 2007-06-01 | 17 |
| K071008 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | NCX | 2007-05-09 | 30 |
| K063405 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | NCX | 2007-01-08 | 60 |
| K042388 | RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE | DQY | 2004-10-28 | 56 |
| K024327 | SETPOINT ENDOVASCULAR TEMPERATURE PROBE | DQY | 2003-03-25 | 89 |
| K012512 | SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM | NCX | 2002-06-11 | 309 |
Recalls
openFDA lists no recalls under a recalling firm named Radiant Medical.
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.
- Radiant Innovation, Inc. (15 510(k)s)
- Radiant Express, LLC (1 510(k)s)
- Radiant Spectacles Manufacturers (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiant Medical?
FDA lists 6 510(k) clearances under the applicant name “Radiant Medical” (first 2002, latest 2007), across 2 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 Radiant Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiant Medical is 58 days.
Which FDA product codes appear under Radiant Medical?
The most frequent FDA product codes under this applicant name are NCX (System, Hypothermia, Intravenous, Cooling, 4); DQY (Catheter, Percutaneous, 2).
Next steps
- See all 6 Radiant Medical clearances with predicates and recalls
- Run predicate analysis for product code NCX, Radiant Medical'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.