# Shenzhen Changkun Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 7 (2020–2026): 7 510(k) clearances
- Product codes: DXN (2), HGX (2), DQA (1), FLL (1), KPI (1)
- 510(k) review time since 2016: median 317 days, against 190 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 5 (1 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
- Shenzhen Bsx Technology Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-bsx-technology-electronics)
- Beijing Choice Electronic Technology Co., Ltd.: 1 (https://510kreport.com/company/beijing-choice-electronic-technology)
- Intrinity Global Limited: 1 (https://510kreport.com/company/intrinity-global)
- Shenzhen Med-Link Electronics Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-med-link-electronics-tech)
- International Trade Group, Inc.: 1 (https://510kreport.com/company/international-trade-group)

## Firms that cite its devices most
- Qingdao Yasee Medical Device Co., Ltd.: 1 (https://510kreport.com/company/qingdao-yasee-medical-device)
- Shenzhen Finicare Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-finicare)
- Shenzhen AOJ Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-aoj-medical-technology)
- Shandong Zhushi Pharmaceutical Group Co., Ltd.: 1 (https://510kreport.com/company/shandong-zhushi-pharmaceutical-group)

## Its most-cited devices
- K193253: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (2020), cited by 4
- K231595: Electric Breast Pump (2023), cited by 1

## Recent decisions
- K250070: Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
- K252552: Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (May 6, 2026)
- K231595: Electric Breast Pump (Oct 26, 2023)
- K221798: Finger Pulse Oximeter, Model: X1906P (May 4, 2023)
- K193387: Arm Electronic Sphygmomanometer (Jan 27, 2021)
- K193386: Wrist Electronic Sphygmomanometer (Jan 27, 2021)
- K193253: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (Jun 17, 2020)

Source page: https://510kreport.com/company/shenzhen-changkun-technology