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510(k) K251974

Arctic Sun Temperature Management System (Model 5000) by Medivance, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
June 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

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 clearances by Medivance, Inc.

  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K200225 — Arctic Sun Stat Temperature Management System (February 28, 2020)
  • K161602 — Arctic Sun Temperature Management System (September 2, 2016)
  • K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, (December 18, 2014)
  • K120849 — HYBRID ARCTICGEL PAD (July 20, 2012)
  • K110956 — MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR (July 18, 2011)
  • K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (July 16, 2010)
  • K080899 — ARCTIC BLAST INTRAVENOUS FLUID CHILLER (August 7, 2008)
  • K071341 — MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 (August 3, 2007)
  • K010338 — ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 (March 7, 2001)

Other clearances for product code DWJ

  • K242964 — Celsi Warmer (June 20, 2025)
  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)
  • K232844 — The IQoolTM System (October 4, 2023)
  • K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
  • K231596 — IOB Temperature Management System (June 30, 2023)
  • K230866 — HotDog Warming Mattress + Return Electrode (June 29, 2023)