# Sunny Medical Device (Shenzhen) Co., Ltd.

- Location (FDA's records): Irvine, CA
- FDA decisions: 6 (2012–2020): 6 510(k) clearances
- Product codes: DQX (2), DXT (1), MAV (1), DQO (1), DXC (1)
- 510(k) review time since 2016: median 288 days, against 179 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 0 (0 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 Ant Hi-Tech Industrial Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-ant-hi-tech-industrial)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Atrion Medical Products, Inc.: 1 (https://510kreport.com/company/atrion-medical-products)
- Coeur, Inc.: 1 (https://510kreport.com/company/coeur)
- Deroyal Industries, Inc.: 1 (https://510kreport.com/company/deroyal-industries)
- Synexmed (Shenzhen)Company Limited: 1 (https://510kreport.com/company/synexmed-shenzhen)
- Jilin Coronado Medical, Ltd.: 1 (https://510kreport.com/company/jilin-coronado-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Recent decisions
- K191827: Sunmed Disposable Angio-Closure Pads (Mar 16, 2020)
- K160190: Sunmed Control Syringes (Nov 10, 2016)
- K153685: Sunmed Haemostatic Valves (Oct 13, 2016)
- K140356: Summed High Pressure Line (Mar 20, 2015)
- K133795: Summed Inflation Device Kit (Dec 12, 2014)
- K120119: Sunmed Guide Wire (May 11, 2012)

Source page: https://510kreport.com/company/sunny-medical-device-shenzhen