Cleared Traditional

K152450 - Esophageal Cooling Device (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152450 · Advanced Cooling Therapy, LLC · Cardiovascular device
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Jan 2016
Decision
140d
Days
Class 2
Risk

K152450 is an FDA 510(k) clearance for the Esophageal Cooling Device. Classified as Esophageal Thermal Regulation And Gastric Suctioning Device (product code PLA), Class II - Special Controls.

Submitted by Advanced Cooling Therapy, LLC (Chicago, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 140 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K152450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2015
Decision Date January 15, 2016
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.