# Bain Medical Equipment (Guangzhou) Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 7 (2017–2026): 7 510(k) clearances
- Product codes: FJK (3), FIE (2), FXX (1), FIB (1)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 5 (3 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
- Nipro Medical Corporation: 3 (https://510kreport.com/company/nipro-medical)
- Xiantao Rayxin Medical Products Co., Ltd.: 1 (https://510kreport.com/company/xiantao-rayxin-medical-products)

## Firms that cite its devices most
- Jiangxi Sanxin Medtec Co., Ltd.: 1 (https://510kreport.com/company/jiangxi-sanxin-medtec)
- Vital Healthcare Sdn. Bhd.: 1 (https://510kreport.com/company/vital-healthcare-sdn-bhd)

## Its most-cited devices
- K201866: NovaLine Tubing Sets for Hemodialysis (2021), cited by 2
- K161582: DORA Tubing Sets for Hemodialysis (2017), cited by 2
- K163025: DORA Disposable A.V. Fistula Needle Sets (2017), cited by 1

## Recent decisions
- K252423: NovaLine Tubing Set for Hemodialysis (BL 124) (May 15, 2026)
- K240164: NovaLine SP-C35 Transducer Protector (956007) (Jun 28, 2024)
- K213015: DORA Disposable A.V. Fistula Needle Sets (Apr 8, 2022)
- K201866: NovaLine Tubing Sets for Hemodialysis (Mar 10, 2021)
- K203524: Surgical Masks (Feb 25, 2021)
- K163025: DORA Disposable A.V. Fistula Needle Sets (Jul 20, 2017)
- K161582: DORA Tubing Sets for Hemodialysis (Jun 16, 2017)

Source page: https://510kreport.com/company/bain-medical-equipment-guangzhou