# Shenzhen Med-Link Electronics Tech Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 14 (2009–2026): 14 510(k) clearances
- Product codes: DQA (4), FLL (3), DXQ (2), DSA (2), GXY (1), KPI (1), DXN (1)
- 510(k) review time since 2016: median 266 days, against 198 for FDA's reviews in the same codes and years (2 of 9 faster)
- Predicates its devices cite: 18 (1 its own); citations of its devices by later devices: 14 (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
- Unimed Medical Supplies, Inc.: 5 (https://510kreport.com/company/unimed-medical-supplies)
- Xuzhou Maicuff Technology Co., Ltd.: 2 (https://510kreport.com/company/xuzhou-maicuff-technology)
- Deroyal Industries, Inc.: 1 (https://510kreport.com/company/deroyal-industries)
- Covidien: 1 (https://510kreport.com/company/covidien)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Fuji Dynamics Limited: 1 (https://510kreport.com/company/fuji-dynamics)
- Shenzhen Launch Electrical Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-launch-electrical)
- Health & Life Co., Ltd.: 1 (https://510kreport.com/company/health-life)

## Firms that cite its devices most
- Shenzhen Coreray Technology, Ltd.: 2 (https://510kreport.com/company/shenzhen-coreray-technology)
- Integral Process Sas: 1 (https://510kreport.com/company/integral-process)
- Shenzhen Upnmed Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-upnmed-equipment)
- Curbell Medical Products, Inc.: 1 (https://510kreport.com/company/curbell-medical-products)
- QT Medical, Inc.: 1 (https://510kreport.com/company/qt-medical)
- Xinkang Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/xinkang-medical-instrument)
- Shenzhen Sino-K Medical Technology Co.,Ltd: 1 (https://510kreport.com/company/shenzhen-sino-k-medical-technology)
- Shenzhen Amydi-Med Electrics Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-amydi-med-electrics-tech)

## Its most-cited devices
- K120010: Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) (2012), cited by 10
- K220448: Disposable Non-invasive EEG Sensor (2023), cited by 1
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (2020), cited by 1
- K181154: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (2019), cited by 1
- K113727: Shenzhen Med-Link Pulse Oximeter Probe (2013), cited by 1

## Recent decisions
- K251160: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (Jan 8, 2026)
- K220448: Disposable Non-invasive EEG Sensor (Jan 19, 2023)
- K220447: Med-link Disposable ECG Cable and Leadwires (Jun 28, 2022)
- K212752: Med-link Pulse Oximeter (May 20, 2022)
- K210441: Incontinence Probe (Sep 17, 2021)
- K202743: Med-Link Temp-pulse Oximeter (Mar 1, 2021)
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (Aug 25, 2020)
- K181154: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (Aug 2, 2019)

Source page: https://510kreport.com/company/shenzhen-med-link-electronics-tech