# DEN140018: Esophageal Cooling Device

- Pathway: De Novo (Direct)
- Applicant: Advanced Cooling Therapy, LLC
- Decided: Jun 23, 2015 after 410 days
- Product code: PLA (Esophageal Thermal Regulation And Gastric Suctioning Device)
- Device class: 2
- Regulation: 21 CFR 870.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K170009: Esophageal Cooling Device (2017), 5 descendants of its own
- K152450: Esophageal Cooling Device (2016), 5 descendants of its own
- K172029: EnsoETM (2018), 2 descendants of its own
- K172493: EnsoETM (2017), 2 descendants of its own
- K180244: EnsoETM (2018), 1 descendant of its own

## Indications for use
The Esophageal Cooling Device is a thermal regulating device, intended to: connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/DEN140018
Methodology: https://510kreport.com/methodology