FDA Product Code MQE: Needle, Assisted Reproduction
Leading manufacturers include Zhejiang Horizon Medical Technology Co., Ltd. and Shenzhen Vitavitro Biotech Co., Ltd..
FDA 510(k) Cleared Needle, Assisted Reproduction Devices (Product Code MQE)
About Product Code MQE - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code MQE since 1999, with 32 receiving FDA clearance (average review time: 145 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under MQE have taken an average of 266 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.
MQE devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →