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

- Pathway: 510(k) (Traditional)
- Applicant: Medivance, Inc.
- Decided: Dec 18, 2014 after 87 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912051 (1991). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101092: Arctic Sun Temperature Management System, Model 5000, Medivance, Inc. (2010) Summary page 4.
- K002577: Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads, Medivance, Inc. (2000) Summary page 4.
- K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900, Gaymar Industries, Inc. (2011) Summary page 4.

## Most influential descendants
- K161602: Arctic Sun Temperature Management System (2016), 3 descendants of its own
- K200225: Arctic Sun Stat Temperature Management System (2020), 1 descendant of its own
- K251974: Arctic Sun Temperature Management System (Model 5000) (2025), 0 descendants of its own
- K243942: Arctic Sun Stat Temperature Management System (2025), 0 descendants of its own

## Recalls of this device
- Feb 16, 2024 · Class II · Z-1381-2024: Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
- Nov 8, 2017 · Class II · Z-1241-2019: Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
- Oct 16, 2017 · Class II · Z-0271-2018: Hydrogel peeling from the pads.
- Jun 2, 2017 · Class III · Z-0590-2018: Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDA
- Jun 30, 2016 · Class III · Z-2345-2016: An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
- Mar 4, 2016 · Class II · Z-1395-2016: Complaints were received of restricted/inaccurate flow rate.

## Indications for use
The Arctic Sun® Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

Source page: https://510kreport.com/device/K142702
Methodology: https://510kreport.com/methodology