FDA Product Code KLA: Monitor, Esophageal Motility, Anorectal Motility, And Tube
Leading manufacturers include Laborie Medical Technologies, Corp., Neuraxis, Inc. and Gi Bionics, LLC.
FDA 510(k) Cleared Monitor, Esophageal Motility, Anorectal Motility, And Tube Devices (Product Code KLA)
About Product Code KLA - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code KLA since 1977, with 31 receiving FDA clearance (average review time: 214 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KLA have taken an average of 142 days to reach a decision - down from 219 days historically, suggesting improved FDA processing for this classification.
KLA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →