Cleared Traditional

K243942 - Arctic Sun Stat Temperature Management ...

K243942 is an FDA 510(k) clearance for Arctic Sun Stat Temperature Management ..., manufactured by Medivance, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K243942 · Medivance, Inc. · Cardiovascular device
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Apr 2025
Decision
131d
Days
Class 2
Risk

K243942 is an FDA 510(k) clearance for the Arctic Sun Stat Temperature Management System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on April 30, 2025 after a review of 131 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 Medivance, Inc. devices

FDA 510(k) Submission Details - K243942

510(k) Number K243942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K243942.
Warming System
K252861 · Hangzhou Tappa Medical Technology Co., Ltd. · Apr 2026
Arctic Sun Temperature Management System (Model 5000)
K251974 · Medivance, Inc. · Oct 2025
Celsi Warmer
K242964 · Hadleigh Health Technologies · Jun 2025
HotDog Warming Mattress + Return Electrode
K232627 · Augustine Temperature Management, LLC · Apr 2024
Cocoon Convective Warming System, Model CWS7000
K232502 · Care Essentials Pty, Ltd. · Feb 2024
Medline ComfortTemp Patient Warming System
K231211 · Medline Industries, LP · Dec 2023