Cleared Traditional

K172029 - EnsoETM

K172029 is an FDA 510(k) clearance for EnsoETM, manufactured by Attune Medical. The device is a Class 2 Cardiovascular device with product code PLA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K172029 · Attune Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2018
Decision
184d
Days
Class 2
Risk

K172029 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 Attune Medical (Chicago, US). The FDA issued a Cleared decision on January 5, 2018 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Attune Medical devices

FDA 510(k) Submission Details - K172029

510(k) Number K172029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date January 05, 2018
Days to Decision 184 days
Submission Type Traditional
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
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K172029.
EsoCool Thermal Regulation Catheter
K233357 · Nuvaira, Inc. · Jun 2024
EnsoETM
K180742 · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · May 2018
EnsoETM
K180244 · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · Feb 2018
EnsoETM
K172493 · Attune Medical · Oct 2017
Esophageal Cooling Device
K170009 · Advanced Cooling Therapy, LLC · Mar 2017
Esophageal Cooling Device
K152450 · Advanced Cooling Therapy, LLC · Jan 2016