FDA Product Code MQH: Microtools, Assisted Reproduction (pipettes)

510(k) Submission Activity

26 total 510(k) submissions under product code MQH since 1999, with 26 receiving FDA clearance (average review time: 153 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under MQH have taken an average of 105 days to reach a decision - down from 155 days historically, suggesting improved FDA processing for this classification.