# K180742: EnsoETM

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Decided: May 17, 2018 after 56 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: 4 generations back to DEN140018 (2015). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180244: EnsoETM, Advanced Cooling Therapy, Inc. D/B/A Attune Medical (2018) Summary page 4.
- K172493: EnsoETM, Attune Medical (2017) Summary page 4.

## Indications for use
Model # ECD05-A: The EnsoETM is a thermal regulating device, intended to: • connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, • allow enteral administration of fluids, and • provide gastric decompression and suctioning. Model # ECD06-A The EnsoETM is a thermal regulating device, intended to: • connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, and • provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/K180742
Methodology: https://510kreport.com/methodology