FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
K Number: K142702
·
Decision Dec 18, 2014
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
12
Review Days
87
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Basic Information
- Device Name
- Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
- K Number
- K142702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medivance, Inc.
- Date Received
- September 22, 2014
- Decision Date
- December 18, 2014
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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Other Clearances by Medivance, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Oct 24, 2025 | Substantially Equivalent |
| K243942 | Arctic Sun Stat Temperature Management System | Apr 30, 2025 | Substantially Equivalent |
| K200225 | Arctic Sun Stat Temperature Management System | Feb 28, 2020 | Substantially Equivalent |
| K161602 | Arctic Sun Temperature Management System | Sep 2, 2016 | Substantially Equivalent |
| K120849 | HYBRID ARCTICGEL PAD | Jul 20, 2012 | Substantially Equivalent |
| K110956 | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR | Jul 18, 2011 | Substantially Equivalent |
| K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 | Jul 16, 2010 | Substantially Equivalent |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | Aug 7, 2008 | Substantially Equivalent |
| K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | Aug 3, 2007 | Substantially Equivalent |
| K010338 | ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 | Mar 7, 2001 | Substantially Equivalent |