Arctic Sun Temperature Management System (Model 5000)
FDA 510(k) K251974 · Medivance, Inc.
510(k) numberK251974
Submission
- Device name
- Arctic Sun Temperature Management System (Model 5000)
- Applicant
- Medivance, Inc.
Louisville, CO, US - Received
- June 26, 2025
- Decision date
- October 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
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).
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| K260903 | Hot Pink Pad Warming SystemDWJ · Traditional | Xodus Medical, Inc. | 04/16/2026SE |
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| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | Medivance, Inc. | 04/30/2025SE |
| K232627 | HotDog Warming Mattress + Return ElectrodeDWJ · Special | Augustine Temperature Management, LLC | 04/18/2024SE |
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | Care Essentials Pty, Ltd. | 02/21/2024SE |
| K231211 | Medline ComfortTemp Patient Warming SystemDWJ · Traditional | Medline Industries, LP | 12/01/2023SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | 04/30/2025SE |
| K200225 | Arctic Sun Stat Temperature Management SystemDWJ · Special | 02/28/2020SE |
| K161602 | Arctic Sun Temperature Management SystemDWJ · Special | 09/02/2016SE |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…DWJ · Traditional | 12/18/2014SE |
| K120849 | Hybrid Arcticgel PadDWJ · Traditional | 07/20/2012SE |
| K110956 | Medivance Nasogastric Tube Temperature SensorFLL · Traditional | 07/18/2011SE |
| K101092 | Arctic Sun Temperature Management System, Model 5000DWJ · Traditional | 07/16/2010SE |
| K080899 | Arctic Blast Intravenous Fluid ChillerNCX · Traditional | 08/07/2008SE |
| K071341 | Modification to Arctic Sun Temperature Management System, Model 2000DWJ · Special | 08/03/2007SE |
| K010338 | Artic Sun Temperature Management System, Model 200DWJ · Special | 03/07/2001SE |
Questions and answers
When was Arctic Sun Temperature Management System (Model 5000) cleared by the FDA?
Arctic Sun Temperature Management System (Model 5000) (K251974) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 120 days after the submission was received.
What is the product code of K251974?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.