FDA Product Code MQL: Media, Reproductive

510(k) Submission Activity

259 total 510(k) submissions under product code MQL since 1987, with 259 receiving FDA clearance (average review time: 158 days).

Submission volume has increased in recent years - 19 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under MQL have taken an average of 196 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.