# Shenzhen Changke Connect Electronics Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 8 (2019–2022): 8 510(k) clearances
- Product codes: DSA (2), DXQ (2), DQA (2), GXY (1), FLL (1)
- 510(k) review time since 2016: median 134 days, against 149 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 1 (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 Caremed Medical Technology Co., Ltd.: 4 (https://510kreport.com/company/shenzhen-caremed-medical-technology)
- Dymedix Diagnostics, Inc.: 1 (https://510kreport.com/company/dymedix-diagnostics)
- Unimed Medical Supplies, Inc.: 1 (https://510kreport.com/company/unimed-medical-supplies)
- Shenzhen Med-Link Electronics Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-med-link-electronics-tech)

## Its most-cited devices
- K191428: ECG Cable (2019), cited by 1

## Recent decisions
- K213884: Disposable EEG cable (May 6, 2022)
- K193625: Disposable Temperature Probe (Jul 24, 2020)
- K200026: Disposable ECG Cable (May 12, 2020)
- K193629: Disposable NIBP Cuff (Mar 25, 2020)
- K200069: Disposable SpO2 Sensor (Mar 13, 2020)
- K191428: ECG Cable (Nov 27, 2019)
- K191420: Reusable SpO2 Sensor (Oct 11, 2019)
- K191253: Reusable NIBP Cuff (Sep 17, 2019)

Source page: https://510kreport.com/company/shenzhen-changke-connect-electronics