FDA Product Code LXC: Monitor, Pressure, Intracompartmental
Leading manufacturers include MY01, Inc..
FDA 510(k) Cleared Monitor, Pressure, Intracompartmental Devices (Product Code LXC)
About Product Code LXC - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code LXC since 1985, with 15 receiving FDA clearance (average review time: 116 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under LXC have taken an average of 189 days to reach a decision - up from 105 days historically. Manufacturers should account for longer review timelines in current project planning.
LXC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →