FDA Product Code MQF: Catheter, Assisted Reproduction
Leading manufacturers include Shenzhen Vitavitro Biotech Co., Ltd., Vitrolife Sweden AB and Guangzhou Hehong Biotech Co., Ltd..
FDA 510(k) Cleared Catheter, Assisted Reproduction Devices (Product Code MQF)
About Product Code MQF - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code MQF since 1998, with 53 receiving FDA clearance (average review time: 148 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MQF have taken an average of 199 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.
MQF devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →