Radiant Innovation, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Radiant Innovation, Inc.” (first 2001, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 166 days, against 209 days for all cleared 510(k)s in the same product codes. 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 | 1 | 64 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 166 |
| 2018 | 1 | 715 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Radiant Innovation, Inc. took a median 166 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 209 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 15 | 15 |
Review panels
- General Hospital (15)
Most recent Radiant Innovation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | FLL | 2024-06-05 | 90 |
| K163601 | RII Smart IR Thermometer | FLL | 2018-12-06 | 715 |
| K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | FLL | 2017-01-09 | 166 |
| K121428 | NON-CONTACT CLINICAL THERMOMETER | FLL | 2012-07-17 | 64 |
| K111637 | INFRARED EAR THERMOMETER | FLL | 2011-12-06 | 176 |
| K103097 | INFRARED EAR THERMOMETER | FLL | 2010-12-29 | 70 |
| K102187 | RII INFRARED EAR THERMOMETER, | FLL | 2010-12-10 | 129 |
| K101253 | RII INFRARED EAR THERMOMETER, MODEL: TH60N | FLL | 2010-06-29 | 56 |
| K070976 | RII INFRARED EAR THERMOMETER, MODEL TH01BN | FLL | 2007-04-20 | 14 |
| K063185 | RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES | FLL | 2006-11-17 | 28 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radiant Innovation, 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.
- Radiant Medical (6 510(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 Innovation, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Radiant Innovation, Inc.” (first 2001, latest 2024), across 1 product code 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 Radiant Innovation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiant Innovation, Inc. is 90 days. Since 2017: 166 days, versus 209 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Radiant Innovation, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 15).
Next steps
- See all 15 Radiant Innovation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Radiant Innovation, 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.