Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad— 510(k) K142702

Clearance details

Applicant

Medivance, Inc.

Product code

Code DWJ

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2014-09-22

Decision date

2014-12-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Louisville, CO, US

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• K252861 — Warming System2026-04-07

• K251974 — Arctic Sun Temperature Management System (Model 5000)2025-10-24
• K243942 — Arctic Sun Stat Temperature Management System2025-04-30
• K200225 — Arctic Sun Stat Temperature Management System2020-02-28
• K161602 — Arctic Sun Temperature Management System2016-09-02
• K120849 — HYBRID ARCTICGEL PAD2012-07-20

Death

7

Injury

679

Malfunction

17,477

Total

18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1381-2024 — Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CClass II·Ongoing·Medivance Inc.·20240216
• Z-1241-2019 — Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.Class II·Terminated·Bard Medical Division·20171108
• Z-0271-2018 — Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿Class II·Terminated·C.R. Bard, Inc.·20171016
• Z-0590-2018 — Arctic Sun ArcticGel Pads - Medium, Product Code 317-07Class III·Ongoing·C.R. Bard, Inc.·20170602
• Z-2345-2016 — Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.Class III·Terminated·C.R. Bard, Inc.·20160630
• Z-1395-2016 — BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.Class II·Terminated·C.R. Bard, Inc.·20160304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142702.