FDA Product Code HIB: Speculum, Vaginal, Nonmetal

510(k) Submission Activity

72 total 510(k) submissions under product code HIB since 1982, with 72 receiving FDA clearance (average review time: 146 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 HIB have taken an average of 234 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.