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510(k) K243942

Arctic Sun Stat Temperature Management System by Medivance, Inc. — Product Code DWJ

K243942 is an FDA 510(k) premarket notification submitted by Medivance, Inc. for the device "Arctic Sun Stat Temperature Management System". The FDA issued a decision of Substantially Equivalent on April 30, 2025. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Medivance, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2025
Date Received
December 20, 2024
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.

  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 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

  • K260278 — ThermAffyx(TM) Patient Safety System (July 8, 2026)
  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K252861 — Warming System (April 7, 2026)
  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K242964 — Celsi Warmer (June 20, 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)

FDA data resources