FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K Number: K010338
·
Decision Mar 7, 2001
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
12
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
- K Number
- K010338
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medivance, Inc.
- Date Received
- February 5, 2001
- Decision Date
- March 7, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWJ), ordered by most recent decision date.
Hot Pink Pad Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Temperature Management System (Model 5000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Celsi Warmer
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Stat Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
HotDog Warming Mattress + Return Electrode
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | Dec 18, 2014 | 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 |