Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radiant Innovation, Inc. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
212 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 | 90 | 0 |
| K163601 | RII Smart IR Thermometer | Radiant Innovation, Inc. | 2018-12-06 | 715 | 0 |
| K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. | 2017-01-09 | 166 | 0 |
| K121428 | NON-CONTACT CLINICAL THERMOMETER | Radiant Innovation, Inc. | 2012-07-17 | 64 | 0 |
| K111637 | INFRARED EAR THERMOMETER | Radiant Innovation, Inc. | 2011-12-06 | 176 | 0 |
| K103097 | INFRARED EAR THERMOMETER | Radiant Innovation, Inc. | 2010-12-29 | 70 | 0 |
| K102187 | RII INFRARED EAR THERMOMETER, | Radiant Innovation, Inc. | 2010-12-10 | 129 | 0 |
| K101253 | RII INFRARED EAR THERMOMETER, MODEL: TH60N | Radiant Innovation, Inc. | 2010-06-29 | 56 | 0 |
| K070976 | RII INFRARED EAR THERMOMETER, MODEL TH01BN | Radiant Innovation, Inc. | 2007-04-20 | 14 | 0 |
| K063185 | RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES | Radiant Innovation, Inc. | 2006-11-17 | 28 | 0 |
| K051269 | RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES | Radiant Innovation, Inc. | 2005-09-09 | 115 | 0 |
| K040377 | RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES | Radiant Innovation, Inc. | 2004-09-16 | 212 | 0 |
| K030324 | RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 | Radiant Innovation, Inc. | 2003-02-27 | 27 | 0 |
| K020504 | INFRARED EAR THERMOMETER, MODELS TH88 SERIES | Radiant Innovation, Inc. | 2002-02-28 | 13 | 0 |
| K011059 | INFARED EAR THERMOMETER, MODEL TH8 SERIES | Radiant Innovation, Inc. | 2001-09-17 | 164 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda