FDA Product Code MQK: Labware, Assisted Reproduction
Leading manufacturers include Cytoswim, Ltd., Cook Incorporated and Gimbo Medical Technology Shenzhen Co., Ltd..
FDA 510(k) Cleared Labware, Assisted Reproduction Devices (Product Code MQK)
About Product Code MQK - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code MQK since 1999, with 50 receiving FDA clearance (average review time: 188 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MQK have taken an average of 216 days to reach a decision - up from 185 days historically. Manufacturers should account for longer review timelines in current project planning.
MQK devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →