ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000— 510(k) K101092
Substantially EquivalentMedivance, Inc.
FDA 510(k) clearance K101092 for ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000, Substantially Equivalent on 2010-07-16. Applicant: Medivance, Inc.. Device class: 2.
Clearance details
- Applicant
- Medivance, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code DWJ
view allMore clearances from Medivance, Inc.
view all- K251974 — Arctic Sun Temperature Management System (Model 5000)
- K243942 — Arctic Sun Stat Temperature Management System
- K200225 — Arctic Sun Stat Temperature Management System
- K161602 — Arctic Sun Temperature Management System
- K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101092
K-number listed on FDA's recall record- Z-3042-2017 — Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
- Z-0760-2016 — Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- Z-1617-2016 — Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101092.
Data sourced from openFDA. This site is unofficial and independent of the FDA.