# K172493: EnsoETM

- Pathway: 510(k) (Traditional)
- Applicant: Attune Medical
- Decided: Oct 17, 2017 after 60 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: 2 generations back to DEN140018 (2015). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K170009: Esophageal Cooling Device, Advanced Cooling Therapy, LLC (2017) Summary page 4.
- K152450: Esophageal Cooling Device, Advanced Cooling Therapy, LLC (2016) Summary page 4.

## Most influential descendants
- K233357: EsoCool Thermal Regulation Catheter (2024), 0 descendants of its own
- K180742: EnsoETM (2018), 0 descendants of its own

## Indications for use
Model #ECD01-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, • and provide gastric decompression and suctioning. Model # ECD02-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, • and provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/K172493
Methodology: https://510kreport.com/methodology