Cleared Traditional

K162523 - The IQool System (FDA 510(k) Clearance)

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

K162523 · Braincool AB · Cardiovascular device
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May 2017
Decision
236d
Days
Class 2
Risk

K162523 is an FDA 510(k) clearance for the The IQool System. Classified as Hyperthermia Monitor (product code NZE), Class II - Special Controls.

Submitted by Braincool AB (Medicon Village, SE). The FDA issued a Cleared decision on May 3, 2017 after a review of 236 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - 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 Braincool AB devices

Submission Details

510(k) Number K162523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2016
Decision Date May 03, 2017
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NZE Hyperthermia Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition Intended To Monitor And Reduce A Patient's Temperature To Mild Hypothermia (not To Go Below 32 Degrees Celsius. To Induce Mild Hypothermia In Hyperthermic Patients E.g., Heat Stroke, Fever (excluding Fever Related To Head Injury, Cardiac Arrest, Or Other Severe Medical Conditions).
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 - NZE Hyperthermia Monitor

Devices cleared under the same product code (NZE) and FDA review panel - the closest regulatory comparables to K162523.
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)
K250979 · Zoll Circulation, Inc. · Oct 2025
CarbonCool® System
K240933 · Global Healthcare SG Sdn. Bhd · Mar 2025
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System
K231182 · Zoll Circulation, Inc. · Nov 2023