FDA Product Code LGZ: Warmer, Thermal, Infusion Fluid
Leading manufacturers include The Surgical Company International B.V., Mequ A/S and Smisson-Cartledge Biomedical, LLC.
FDA 510(k) Cleared Warmer, Thermal, Infusion Fluid Devices (Product Code LGZ)
About Product Code LGZ - Regulatory Context
510(k) Submission Activity
75 total 510(k) submissions under product code LGZ since 1981, with 75 receiving FDA clearance (average review time: 176 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under LGZ have taken an average of 133 days to reach a decision - down from 178 days historically, suggesting improved FDA processing for this classification.
LGZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →