Cleared Traditional

The IQoolTM Warm System (K180375) - FDA 510(k) Clearance

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

K180375 · Braincool AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
95d
Days
Class 2
Risk

K180375 is an FDA 510(k) clearance for the The IQoolTM Warm System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Braincool AB (Medicon Village, SE). The FDA issued a Cleared decision on May 18, 2018 after a review of 95 days - within the typical 510(k) review window.

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 K180375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date May 18, 2018
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Consultant

Target Health, Inc.
Adam Harris

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWJ System, Thermal Regulating

All 32
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K180375.
Cocoon Convective Warming System
K181671 · Care Essentials Pty, Ltd. · May 2019
Altrix Precision Temperature Management System
K180834 · Stryker Medical · Aug 2018
Level 1 Convective Warmer
K181699 · Smiths Medical Asd, Inc. · Jul 2018
3M Bair Hugger Model 675 Total Temperature Management System
K171373 · 3M Company · Oct 2017
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
K131361 · Covidien · Jul 2013
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · Covidien · Apr 2013