Cleared Traditional

K142702 - Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad

K142702 is an FDA 510(k) clearance for Arctic Sun Temperature Management System, 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 87-day FDA review.

K142702 · Medivance, Inc. · Cardiovascular device
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Dec 2014
Decision
87d
Days
Class 2
Risk

K142702 is an FDA 510(k) clearance for the Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS,.... 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 December 18, 2014 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medivance, Inc. devices

FDA 510(k) Submission Details - K142702

510(k) Number K142702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date December 18, 2014
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 129
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K142702.
OPT-SHIELD AIR, SUPINE
K162562 · Bcg Medical, LLC · Mar 2017
Altrix Precision Temperature Management System
K152266 · Stryker Medical · Dec 2016
Arctic Sun Temperature Management System
K161602 · Medivance, Inc. · Sep 2016
TECOTHERM NEO (T NEO)
K140078 · Inspiration Healthcare, Ltd. · Nov 2014
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
K141686 · Smith Medical Asd, Inc. · Oct 2014
COCOON CONVECTIVE WARMING SYSTEM
K140635 · Care Essentials Pty, Ltd. · Jul 2014