FDA Product Code KRA: Catheter, Continuous Flush
FDA product code KRA covers continuous flush catheters used for hemodynamic pressure monitoring.
These catheters incorporate a slow continuous infusion mechanism that maintains line patency and prevents thrombus formation in arterial pressure monitoring lines and pulmonary artery catheters. They deliver a controlled flush rate of 3 mL/hour without requiring manual flushing.
KRA devices are Class II medical devices, regulated under 21 CFR 870.1210 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Medos International SARL, Suzhou Zenith Vascular SciTech Limited and Invera Medical.
FDA 510(k) Cleared Catheter, Continuous Flush Devices (Product Code KRA)
About Product Code KRA - Regulatory Context
510(k) Submission Activity
173 total 510(k) submissions under product code KRA since 1977, with 173 receiving FDA clearance (average review time: 122 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under KRA have taken an average of 310 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.
KRA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →