Cleared Traditional

Arctic Sun Temperature Management System (Model 5000)

K251974 · Medivance, Inc. · Cardiovascular

Oct 2025

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K251974 is an FDA 510(k) clearance for the Arctic Sun Temperature Management System (Model 5000), a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on October 24, 2025, 120 days after receiving the submission on June 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K251974 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2025
Decision Date	October 24, 2025
Days to Decision	120 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).