FDA Product Code POD: Temporary, Internal Use Hemostatic
Intended To Control Severely Bleeding Wounds
Leading manufacturers include Teleflex Medical.
FDA 510(k) Cleared Temporary, Internal Use Hemostatic Devices (Product Code POD)
About Product Code POD - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code POD since 2017, with 5 receiving FDA clearance (average review time: 285 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under POD have taken an average of 120 days to reach a decision - down from 318 days historically, suggesting improved FDA processing for this classification.
POD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →