Cleared Special

Arctic Sun Temperature Management System (K161602) - FDA 510(k) Clearance

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

K161602 · Medivance, Inc. · Cardiovascular device
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Sep 2016
Decision
85d
Days
Class 2
Risk

K161602 is an FDA 510(k) clearance for the Arctic Sun 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 September 2, 2016 after a review of 85 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 Medivance, Inc. devices

Submission Details

510(k) Number K161602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2016
Decision Date September 02, 2016
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K161602.
Level 1 Convective Warmer
K181699 · Smiths Medical Asd, Inc. · Jul 2018
The IQoolTM Warm System
K180375 · Braincool AB · May 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
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990