# K180244: EnsoETM

- Pathway: 510(k) (Special)
- Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Decided: Feb 28, 2018 after 30 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: 3 generations back to DEN140018 (2015). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172029: EnsoETM, Attune Medical (2018) Summary page 4.

## Most influential descendants
- K180742: EnsoETM (2018), 0 descendants of its own

## Indications for use
Model # ECD03-A: The EnsoETM 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, • allow enteral administration of fluids, • and provide gastric decompression and suctioning. Model # ECD04-A: The EnsoETM is a thermal regulating device, intended to: • connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, • allow enteral administration of fluids, • and provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/K180244
Methodology: https://510kreport.com/methodology