# Azur Medical Company, Inc.

- Location (FDA's records): Richmond, VA
- FDA decisions: 4 (2021–2024): 4 510(k) clearances
- Product codes: FMF (2), FMI (1), FXX (1)
- 510(k) review time since 2016: median 227 days, against 193 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 4 (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
- Guangdong Intmed Medical Appliance Co., Ltd.: 1 (https://510kreport.com/company/guangdong-intmed-medical-appliance)
- Berpu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/berpu-medical-technology)
- Shanghai Kindly Enterprise Dev. Group Co.,: 1 (https://510kreport.com/company/shanghai-kindly-enterprise-dev-group)
- Tianjin Aoshang Outdoor Equipment Co., Ltd.: 1 (https://510kreport.com/company/tianjin-aoshang-outdoor-equipment)

## Firms that cite its devices most
- CMT Health PTE., Ltd.: 2 (https://510kreport.com/company/cmt-health)
- Zhejiang Kindly Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-kindly-medical-devices)
- Revital Healthcare (Epz) Limited: 1 (https://510kreport.com/company/revital-healthcare-epz)

## Its most-cited devices
- K211214: Sterile Hypodermic Needles for Single Use (2021), cited by 3
- K211211: Sterile syringes for single use with/without needle (2021), cited by 1

## Recent decisions
- K231719: Medical Surgical Mask (Mar 19, 2024)
- K211210: Sterile Auto-Disable Syringes with/without Needle for Single Use (Jan 27, 2022)
- K211214: Sterile Hypodermic Needles for Single Use (Oct 14, 2021)
- K211211: Sterile syringes for single use with/without needle (Oct 7, 2021)

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