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510(k) K232627

HotDog Warming Mattress + Return Electrode by Augustine Temperature Management, LLC — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2024
Date Received
August 29, 2023
Clearance Type
Special
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 Augustine Temperature Management, LLC

  • K230866 — HotDog Warming Mattress + Return Electrode (June 29, 2023)
  • K220941 — HotDog Temperature Management System (September 23, 2022)
  • K210727 — HotDog Warming Mattress + Return Electrode (February 1, 2022)
  • K201779 — HotDog Temperature Management Controller (September 11, 2020)

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)
  • 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)