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 Advanced Cooling Therapy, Inc. D/B/A Attune Medical, Attune Medical and Nuvaira, Inc..
9
Total
8
Cleared
164d
Avg days
2015
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
241d
recently vs 155d historically
FDA 510(k) Cleared Esophageal Thermal Regulation And Gastric Suctioning Device Devices (Product Code PLA)
9 devices
Cleared
Oct 30, 2025
Arctx Cool Catheter Set
Arctx Medical
Cardiovascular
241d
Cleared
Jun 27, 2024
EsoCool Thermal Regulation Catheter
Nuvaira, Inc.
Cardiovascular
272d
Cleared
May 17, 2018
EnsoETM
Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Cardiovascular
56d
Cleared
Feb 28, 2018
EnsoETM
Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Cardiovascular
30d
Cleared
Jan 05, 2018
EnsoETM
Attune Medical
Cardiovascular
184d
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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - PLA Product Code
Recent submissions under PLA have taken an average of 241 days to reach a decision - up from 155 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 →