Cleared Traditional

Arctic Sun Stat Temperature Management System

K243942 · Medivance, Inc. · Cardiovascular

Apr 2025

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K243942 is an FDA 510(k) clearance for the Arctic Sun Stat Temperature Management System, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on April 30, 2025, 131 days after receiving the submission on December 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K243942 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	April 30, 2025
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — 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).