# Guangzhou Berrcom Medical Device Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 6 (2019–2023): 6 510(k) clearances
- Product codes: FLL (6)
- 510(k) review time since 2016: median 151 days, against 218 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 6 (2 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
- Radiant Innovation, Inc.: 1 (https://510kreport.com/company/radiant-innovation)
- Smart Technology Co., Ltd.: 1 (https://510kreport.com/company/smart-technology)
- Broadmaster Biotech, Corp.: 1 (https://510kreport.com/company/broadmaster-biotech)

## Firms that cite its devices most
- Andon Health Co, Ltd.: 2 (https://510kreport.com/company/andon-health)
- Bioland Technology, Ltd.: 1 (https://510kreport.com/company/bioland-technology)
- Shenzhen Sonida Digital Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-sonida-digital-technology)

## Its most-cited devices
- K191570: Infrared Thermometer Model MD-H30 (2019), cited by 6

## Recent decisions
- K214077: Digital Thermometer, Model: DT007, DT008 (Jan 20, 2023)
- K213746: Digital thermometer, Model DT101, DT102 (Apr 5, 2022)
- K213084: Ear Thermometer, Model ET005, ET008, ET009 (Feb 25, 2022)
- K213079: Ear Thermometer, Model ET001 (Feb 18, 2022)
- K213082: Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 (Jan 28, 2022)
- K191570: Infrared Thermometer Model MD-H30 (Nov 13, 2019)

Source page: https://510kreport.com/company/guangzhou-berrcom-medical-device