Cleared Special

The IQoolTM System (K232844) - FDA 510(k) Clearance

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

K232844 · Braincool AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
20d
Days
Class 2
Risk

K232844 is an FDA 510(k) clearance for the The IQoolTM System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Braincool AB (Lund, SE). The FDA issued a Cleared decision on October 4, 2023 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Braincool AB devices

Submission Details

510(k) Number K232844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2023
Decision Date October 04, 2023
Days to Decision 20 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DWJ System, Thermal Regulating

All 32
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K232844.
Cocoon Convective Warming System, Model CWS7000
K232502 · Care Essentials Pty, Ltd. · Feb 2024
Medline ComfortTemp Patient Warming System
K231211 · Medline Industries, LP · Dec 2023
FilteredFlo Warming Blankets
K232638 · Iob Medical, Inc. · Oct 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · Molnlycke Health Care Us, LLC · Sep 2023
IOB Temperature Management System
K231596 · Iob Medical, Inc. · Jun 2023
HotDog Warming Mattress + Return Electrode
K230866 · Augustine Temperature Management, LLC · Jun 2023