Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads
FDA 510(k) K002577 · Medivance, Inc.
510(k) numberK002577
Submission
- Device name
- Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads
- Applicant
- Medivance, Inc.
Louisville, CO, US - Received
- August 18, 2000
- Decision date
- October 26, 2000
- 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).
Other 510(k)s with product code DWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
| K261437 | Mistral-Air® Warming SystemDWJ · Special | The Surgical Company International B.V., doing… | 08/07/2026SE |
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | Stihler Electronic GmbH | 07/08/2026SE |
| K260903 | Hot Pink Pad Warming SystemDWJ · Traditional | Xodus Medical, Inc. | 04/16/2026SE |
| K252861 | Warming SystemDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 04/07/2026SE |
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | Medivance, Inc. | 10/24/2025SE |
| 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 |
More from Care Essentials Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | 10/24/2025SE |
| 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 |
Questions and answers
When was Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads cleared by the FDA?
Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads (K002577) received a 510(k) decision of Substantially Equivalent on October 26, 2000, 69 days after the submission was received.
What is the product code of K002577?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.