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510(k) K232502

Cocoon Convective Warming System, Model CWS7000 by Care Essentials Pty, Ltd. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2024
Date Received
August 18, 2023
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 Care Essentials Pty, Ltd.

  • K213907 — CareGUARD Sterilization Wrap (March 14, 2022)
  • K181671 — Cocoon Convective Warming System (May 2, 2019)
  • K140635 — COCOON CONVECTIVE WARMING SYSTEM (July 25, 2014)

Other clearances for product code DWJ

  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • 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)
  • 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)