# Anrei Medical (Hangzhou) Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 6 (2020–2022): 6 510(k) clearances
- Product codes: GCA (1), EOQ (1), PKL (1), ODC (1), FBK (1), KNS (1)
- 510(k) review time since 2016: median 197 days, against 167 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 5 (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
- Micro-Tech (Nanjing) Co., Ltd.: 3 (https://510kreport.com/company/micro-tech-nanjing)
- Byrne Medical, Inc.: 3 (https://510kreport.com/company/byrne-medical)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Hangzhou AGS MedTech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-ags-medtech)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)

## Firms that cite its devices most
- Beijing Zksk Technology Co., Ltd.: 2 (https://510kreport.com/company/beijing-zksk-technology)
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-vedkang-medical-science-and-technology)
- Alton (Shanghai) Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/alton-shanghai-medical-instruments)
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)

## Its most-cited devices
- K210917: Single Use Injection Needle (2021), cited by 3
- K210660: Stone Retrieval Balloon Catheter (2021), cited by 1
- K201771: Single Use Rotatable and Repositionable Hemoclip (2020), cited by 1

## Recent decisions
- K212999: Multi-Functional Electrosurgical Knife (Mar 21, 2022)
- K210917: Single Use Injection Needle (May 28, 2021)
- K202987: Rescue Pulmonary Grasping Forceps (Apr 29, 2021)
- K210660: Stone Retrieval Balloon Catheter (Apr 27, 2021)
- K201771: Single Use Rotatable and Repositionable Hemoclip (Oct 19, 2020)
- K192048: Single Use Endoscope Valves Set (May 14, 2020)

Source page: https://510kreport.com/company/anrei-medical-hangzhou