Not Cleared Direct

DEN140018 - ESOPHAGEAL COOLING DEVICE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140018 · Advanced Cooling Therapy, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
410d
Days
Class 2
Risk

DEN140018 is an FDA 510(k) submission (not cleared) 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 Not Cleared (DENG) decision on June 23, 2015 after a review of 410 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 410 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Advanced Cooling Therapy, LLC devices

Submission Details

510(k) Number DEN140018 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 09, 2014
Decision Date June 23, 2015
Days to Decision 410 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 125d · This submission: 410d
Pathway characteristics

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.