FDA Product Code LDR: Controller, Infusion, Intravascular, Electronic

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 510(k) Review Time - LDR Product Code

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 →

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