FDA Product Code PLA: Esophageal Thermal Regulation And Gastric Suctioning Device
The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage.
Leading manufacturers include Nuvaira, Inc. and Arctx Medical.
FDA 510(k) Cleared Esophageal Thermal Regulation And Gastric Suctioning Device Devices (Product Code PLA)
About Product Code PLA - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PLA since 2015, with 8 receiving FDA clearance (average review time: 164 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PLA have taken an average of 257 days to reach a decision - up from 138 days historically. Manufacturers should account for longer review timelines in current project planning.
PLA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →