FDA Product Code LDR: Controller, Infusion, Intravascular, Electronic
Leading manufacturers include Deka Research and Development and Deka Research and Development Corporation.
FDA 510(k) Cleared Controller, Infusion, Intravascular, Electronic Devices (Product Code LDR)
About Product Code LDR - Regulatory Context
510(k) Submission Activity
60 total 510(k) submissions under product code LDR since 1976, with 60 receiving FDA clearance (average review time: 83 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under LDR have taken an average of 28 days to reach a decision - down from 84 days historically, suggesting improved FDA processing for this classification.
LDR devices are reviewed by the General Hospital panel. Browse all General Hospital devices →