MQG · Class II · 21 CFR 884.6120

FDA Product Code MQG: Accessory, Assisted Reproduction

Leading manufacturers include Genea Biomedx Pty, Ltd., Vitrolife A/S and Wuhan Huchuang Union Technology Co., Ltd..

46
Total
46
Cleared
165d
Avg days
1998
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 177d avg (recent)

FDA 510(k) Cleared Accessory, Assisted Reproduction Devices (Product Code MQG)

46 devices
1–24 of 46

About Product Code MQG - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code MQG since 1998, with 46 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MQG Product Code

FDA review times for MQG submissions have been consistent, averaging 177 days recently vs 165 days historically.

MQG devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →