FDA Product Code HGX: Pump, Breast, Powered

510(k) Submission Activity

235 total 510(k) submissions under product code HGX since 1980, with 235 receiving FDA clearance (average review time: 167 days).

Submission volume has increased in recent years - 53 submissions in the last 24 months compared to 30 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under HGX have taken an average of 144 days to reach a decision - down from 174 days historically, suggesting improved FDA processing for this classification.