Arctic Sun Temperature Management System, ArcticGel Pads (Universal XXS, XS, S, M, L, Small Universal, Neonatal)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142702 FDA 510(k)
- FDA Product Code
- DWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5900 FDA 510(k)
- Regulation Number
- 870.5900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arctic Sun Temperature Management System is a Thermal Regulating System (OpenFDA classification: DWJ) designed for non-invasive monitoring and control of patient temperature in adult, pediatric, and neonatal patients. It employs conductive ArcticGel pads to regulate core temperature within a range of 32°C to 38.5°C, ensuring precise thermal management without direct invasive methods.
The system consists of a reusable Arctic Sun 5000 Control Module paired with single-use ArcticGel pads in multiple sizes (Universal XXS, XS, S, M, L, Small Universal, Neonatal). Pads are sterile, disposable, and intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. Authorized under FDA 510K and MDR, the device adheres to regulatory standards for Class II medical devices (OpenFDA: 870.5900).
Frequently asked questions
What patient populations can the Arctic Sun Temperature Management System be used for, and how does it differ between them?
The Arctic Sun Temperature Management System is designed for non-invasive temperature regulation in adults, pediatric patients, and neonates, with specific pad sizes tailored to each group. The Universal XXS, XS, S, M, and L pads are intended for adult and pediatric patients, while the Small Universal and Neonatal pads are optimized for smaller or newborn patients. The system ensures precise thermal control (32°C to 38.5°C) without invasive methods, making it versatile for critical care settings like ORs, ICUs, and ERs.
Are the ArcticGel pads reusable, and if not, how should they be disposed of after single-use?
The ArcticGel pads are single-use, sterile, and disposable—they are not designed for reuse. After use, they should be discarded following standard clinical waste protocols for medical devices. The reusable component of the system is the Arctic Sun 5000 Control Module, which pairs with new pads for each patient.
What storage conditions are required for the ArcticGel pads before use?
The ArcticGel pads are sterile and must be stored in their original packaging to maintain sterility. They should be kept in a cool, dry environment away from direct sunlight or extreme temperatures until ready for use. Check the packaging for expiration dates, as these pads are not intended for long-term storage beyond their shelf life.
How does the Arctic Sun system regulate temperature, and what temperature range does it maintain?
The system uses conductive ArcticGel pads to transfer heat or coolness to the patient’s skin, working in conjunction with the reusable Arctic Sun 5000 Control Module to regulate core temperature. It maintains a precise range of 32°C to 38.5°C, making it suitable for hypothermia prevention, fever management, and post-operative temperature stabilization in various clinical settings.
What regulatory pathways does the Arctic Sun Temperature Management System follow, and what does that mean for clinicians?
The system is authorized under FDA 510(k) clearance and MDR (Medical Device Regulation) in the EU, classifying it as a Class II medical device under OpenFDA’s DWJ (Thermal Regulating System) product code. This means it has undergone rigorous review for safety and effectiveness, ensuring compliance with regulatory standards for non-invasive temperature management in adult, pediatric, and neonatal patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Arctic Sun Temperature Management System, ArcticGel Pads (Universal ..., BD ArcticGel™ Pads, Arctic Sun Temperature Management System, ArcticGel Pads (Universal ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K142702 | Class II | Active |
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Manufacturer
- Manufacturer
- Medivance, Inc.
Sources (2)
- FDA 510(k) K142702 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 11, 2026