# Guangdong Biolight Meditech Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 21 (2008–2019): 21 510(k) clearances
- Product codes: MWI (7), MHX (5), DQA (4), HGM (2), DPS (1), DXN (1), FLL (1)
- 510(k) review time since 2016: median 148 days, against 165 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 28 (13 its own); citations of its devices by later devices: 19 (13 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
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Beijing Choice Electronic Technololgy Co., Ltd.: 2 (https://510kreport.com/company/beijing-choice-electronic-technololgy)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Kendall: 1 (https://510kreport.com/company/kendall)
- Aspect Medical Systems, Inc.: 1 (https://510kreport.com/company/aspect-medical-systems)
- Shenzhen Biocare Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-biocare-electronics)
- Civnet Communication, Ltd.: 1 (https://510kreport.com/company/civnet-communication)
- Shenzhen Pango Electronic Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-pango-electronic)

## Firms that cite its devices most
- Fudakang Industrial Co., Ltd.: 1 (https://510kreport.com/company/fudakang-industrial)
- Rudolf Riester GmbH & Co. KG: 1 (https://510kreport.com/company/rudolf-riester)
- Viatom Technology Co., Ltd.: 1 (https://510kreport.com/company/viatom-technology)
- Laerdal Medical Corp.: 1 (https://510kreport.com/company/laerdal-medical)
- Digicare Biomedical Technology, Inc.: 1 (https://510kreport.com/company/digicare-biomedical-technology)
- Mid-Link Consulting Co, Ltd.: 1 (https://510kreport.com/company/mid-link-consulting)

## Its most-cited devices
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 (2010), cited by 6
- K081712: Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700 (2008), cited by 3
- K153135: Vital Signs Monitor (2016), cited by 2
- K120193: Any View Patient Monitors (2012), cited by 2
- K131762: Handheld Monitor (2014), cited by 2
- K131898: A Series and Q Series Patient Monitors (2014), cited by 1

## Recent decisions
- K181919: Patient Monitor (Apr 5, 2019)
- K170514: Central Monitoring System (May 24, 2017)
- K162234: Truscope Ultra Patient Monitor (Jan 4, 2017)
- K160349: Electronic Sphygmomanometer (Nov 3, 2016)
- K153580: Central Monitoring System (Sep 7, 2016)
- K153135: Vital Signs Monitor (Feb 25, 2016)
- K152739: Electronic Thermometer (Feb 9, 2016)
- K151287: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (Jan 6, 2016)

Source page: https://510kreport.com/company/guangdong-biolight-meditech