FDA Product Code FMG: Stopcock, I.v. Set
Leading manufacturers include Baxter Healthcare Corporation and Medex.
FDA 510(k) Cleared Stopcock, I.v. Set Devices (Product Code FMG)
About Product Code FMG - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code FMG since 1976, with 89 receiving FDA clearance (average review time: 94 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under FMG have taken an average of 272 days to reach a decision - up from 92 days historically. Manufacturers should account for longer review timelines in current project planning.
FMG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →