# K170009: Esophageal Cooling Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cooling Therapy, LLC
- Decided: Mar 30, 2017 after 86 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
Longest line of descent: 1 generation back to DEN140018 (2015). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140018: Esophageal Cooling Device, Advanced Cooling Therapy, LLC (2015) Summary page 4.

## Most influential descendants
- K172029: EnsoETM (2018), 2 descendants of its own
- K172493: EnsoETM (2017), 2 descendants of its own
- K180244: EnsoETM (2018), 1 descendant of its own
- K233357: EsoCool Thermal Regulation Catheter (2024), 0 descendants of its own
- K180742: EnsoETM (2018), 0 descendants 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 or Stryker Altrix Precision Temperature Management System to control patient temperature, and • provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/K170009
Methodology: https://510kreport.com/methodology