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EnsoETM

by Advanced Cooling Therapy, Inc. D/B/A Attune Medical 3 variants

510(k) K180742

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180742↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK180742 Date17 May 2018ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PLA
Device Class
Class II
Regulation
21 CFR Part 870.5910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EnsoETM is an esophageal thermal regulation and gastric suctioning device, designed to manage hypothermia and facilitate gastric decompression in post-cardiac arrest patients. It combines temperature modulation via a thermal exchange catheter with continuous gastric suction to stabilize core body temperature and reduce gastric distension, supporting critical care interventions during resuscitation and recovery phases.

This device is intended for single-use in clinical settings, including emergency departments, intensive care units, and cardiac catheterization labs. Supplied sterile in a sealed, ready-to-use package, it must be handled with aseptic technique and discarded after one use. The device complies with FDA 510(k) clearance (K180742) and EU MDD directives, with a classification under FDA regulation 870.5910 as a Class II medical device. No MRI safety information is specified, and storage requires protection from contamination and mechanical damage.

Other devices from Advanced Cooling Therapy, Inc. D/B/A Attune Medical

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is the EnsoETM designed to address in post-cardiac arrest patients?

    The EnsoETM is specifically designed to manage hypothermia and reduce gastric distension in post-cardiac arrest patients during critical care interventions. It combines temperature modulation via a thermal exchange catheter with continuous gastric suctioning to stabilize core body temperature and support resuscitation efforts in settings like emergency departments, intensive care units, and cardiac catheterization labs.

  • Is the EnsoETM intended for reuse, or is it meant to be used only once?

    The EnsoETM is explicitly designed for single-use only in clinical settings. It is supplied sterile in a sealed package and must be discarded after one use to maintain aseptic technique and prevent contamination.

  • How should the EnsoETM be stored to ensure it remains functional and uncontaminated?

    The device must be stored in a clean, dry environment protected from contamination and mechanical damage. Since it is sterile upon packaging, it should remain in its sealed packaging until use to preserve sterility.

  • What types of facilities or departments would typically use the EnsoETM?

    The EnsoETM is intended for use in high-acuity settings where post-cardiac arrest patients require temperature stabilization and gastric decompression, including emergency departments, intensive care units (ICUs), and cardiac catheterization labs.

  • Does the EnsoETM have any specific MRI safety considerations?

    The device documentation does not specify any MRI safety information, meaning its compatibility with MRI environments (e.g., whether it can be safely used or scanned) is not addressed. Clinicians should exercise caution and verify compatibility before use in MRI settings.