Cleared Special

K180244 - EnsoETM

K180244 is an FDA 510(k) clearance for EnsoETM, manufactured by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. The device is a Class 2 Cardiovascular device with product code PLA cleared through the Special 510(k) pathway after a 30-day FDA review.

K180244 · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · Cardiovascular device
Download Printable Device Report (PDF)
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Feb 2018
Decision
30d
Days
Class 2
Risk

K180244 is an FDA 510(k) clearance for the EnsoETM. Classified as Esophageal Thermal Regulation And Gastric Suctioning Device (product code PLA), Class II - Special Controls.

Submitted by Advanced Cooling Therapy, Inc. D/B/A Attune Medical (Chicago, US). The FDA issued a Cleared decision on February 28, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Cooling Therapy, Inc. D/B/A Attune Medical devices

FDA 510(k) Submission Details - K180244

510(k) Number K180244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date February 28, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

PLA Device Classification - Class 2, Special Controls

Product Code PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5910
Definition The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PLA Esophageal Thermal Regulation And Gastric Suctioning Device

All 8
Devices cleared under the same product code (PLA) and FDA review panel - the closest regulatory comparables to K180244.
Arctx Cool Catheter Set
K250632 · Arctx Medical · Oct 2025
EsoCool Thermal Regulation Catheter
K233357 · Nuvaira, Inc. · Jun 2024
EnsoETM
K180742 · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · May 2018
EnsoETM
K172029 · Attune Medical · Jan 2018
EnsoETM
K172493 · Attune Medical · Oct 2017
Esophageal Cooling Device
K170009 · Advanced Cooling Therapy, LLC · Mar 2017