# Shenzhen HugeMed Medical Technical Development Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 8 (2023–2026): 8 510(k) clearances
- Product codes: FBN (2), EOQ (1), FED (1), FAJ (1), EOB (1), FGB (1), BTA (1)
- 510(k) review time since 2016: median 160 days, against 155 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 8 (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
- Ambu A/S: 3 (https://510kreport.com/company/ambu-a-s)
- Dongguan Zsr Biomedical Technology Company Limited: 1 (https://510kreport.com/company/dongguan-zsr-biomedical-technology)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- OTU Medical, Inc.: 1 (https://510kreport.com/company/otu-medical)
- Huger Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/huger-medical-instrument)
- Medela AG: 1 (https://510kreport.com/company/medela)

## Recent decisions
- K260892: Suction Pump (SU-90) (May 14, 2026)
- K250695: Single-use Ureteral Access Sheath (Jul 8, 2025)
- K241444: Biliary Pancreaticobiliary Scope System (Jan 21, 2025)
- K240374: Ureterorenoscope System (May 10, 2024)
- K232435: Rhinolaryngoscope system (Apr 26, 2024)
- K231497: Choledochoscope System (Mar 6, 2024)
- K231118: Cystoscope System (Nov 13, 2023)
- K222910: Bronchoscope System (Apr 11, 2023)

Source page: https://510kreport.com/company/shenzhen-hugemed-medical-technical-development