# Guangdong Transtek Medical Electronics Co., Ltd.

- Location (FDA's records): Zhongshan, CN
- FDA decisions: 17 (2013–2025): 17 510(k) clearances
- Product codes: DXN (14), MNW (2), NBW (1)
- 510(k) review time since 2016: median 100 days, against 156 for FDA's reviews in the same codes and years (9 of 13 faster)
- Predicates its devices cite: 16 (9 its own); citations of its devices by later devices: 15 (9 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
- Zhongshan Transtek Electronics Co., Ltd.: 4 (https://510kreport.com/company/zhongshan-transtek-electronics)
- Vivachek Biotech (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/vivachek-biotech-hangzhou)
- Microlife Intellectual Property GmbH: 1 (https://510kreport.com/company/microlife-intellectual-property)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)

## Firms that cite its devices most
- Joytech Healthcare Co., Ltd.: 4 (https://510kreport.com/company/joytech-healthcare)
- Aktiia SA: 1 (https://510kreport.com/company/aktiia)
- Shenzhen Ziqing Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-ziqing-medical-equipment)

## Its most-cited devices
- K202891: Blood Pressure Monitor (2021), cited by 3
- K232621: Blood pressure monitor (2023), cited by 3
- K232713: Blood Pressure Monitor (2023), cited by 2
- K161886: Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device (2016), cited by 2
- K131395: Transtek Blood Pressure Monitor (2013), cited by 2
- K240254: Blood Pressure Monitor (TMB-2296-BT) (2024), cited by 1

## Recent decisions
- K243060: TeleRPM Gen2 Blood Glucose Monitoring System (Jan 30, 2025)
- K241351: Blood Pressure Monitor (TMB-2092-G) (Aug 21, 2024)
- K240832: Blood Pressure Monitor (BBZ32-AA01) (Jun 7, 2024)
- K240254: Blood Pressure Monitor (TMB-2296-BT) (May 31, 2024)
- K240102: Blood Pressure Monitor (TMB-2287-B) (Apr 29, 2024)
- K233130: Blood Pressure Monitor (Dec 20, 2023)
- K232713: Blood Pressure Monitor (Nov 28, 2023)
- K232621: Blood pressure monitor (Nov 22, 2023)

Source page: https://510kreport.com/company/guangdong-transtek-medical-electronics