# Radiant Innovation, Inc.

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 15 (2001–2024): 15 510(k) clearances
- Product codes: FLL (15)
- 510(k) review time since 2016: median 166 days, against 209 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 16 (15 its own); citations of its devices by later devices: 26 (15 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tecnimed S.R.L.: 1 (https://510kreport.com/company/tecnimed)

## Firms that cite its devices most
- Joytech Healthcare Co., Ltd.: 2 (https://510kreport.com/company/joytech-healthcare)
- Hetaida Technology Co., Ltd.: 2 (https://510kreport.com/company/hetaida-technology)
- Dongguan Simzo Electronic Technology Co., Ltd.: 1 (https://510kreport.com/company/dongguan-simzo-electronic-technology)
- Remote Diagnostic Technologies, Ltd.: 1 (https://510kreport.com/company/remote-diagnostic-technologies)
- Guangzhou Berrcom Medical Device Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-berrcom-medical-device)
- Innochips Technology Co., Ltd.: 1 (https://510kreport.com/company/innochips-technology)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)
- Guangdong Biolight Meditech Co., Ltd.: 1 (https://510kreport.com/company/guangdong-biolight-meditech)

## Its most-cited devices
- K011059: Infared Ear Thermometer, Model TH8 Series (2001), cited by 8
- K121428: Non-Contact Clinical Thermometer (2012), cited by 5
- K063185: Rii Infrared Ear Thermometer, Models TH5XY Series (2006), cited by 3
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z (2017), cited by 3
- K111637: Infrared Ear Thermometer (2011), cited by 2
- K051269: Rii Infrared Ear Thermometer, Models TH00XY Series (2005), cited by 1

## Recent decisions
- K240648: Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) (Jun 5, 2024)
- K163601: RII Smart IR Thermometer (Dec 6, 2018)
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z (Jan 9, 2017)
- K121428: Non-Contact Clinical Thermometer (Jul 17, 2012)
- K111637: Infrared Ear Thermometer (Dec 6, 2011)
- K103097: Infrared Ear Thermometer (Dec 29, 2010)
- K102187: Rii Infrared Ear Thermometer, (Dec 10, 2010)
- K101253: Rii Infrared Ear Thermometer, Model: TH60N (Jun 29, 2010)

Source page: https://510kreport.com/company/radiant-innovation