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510(k) K260903

Hot Pink Pad Warming System by Xodus Medical, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
March 18, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Xodus Medical, Inc.

  • K182080 — Scope Antifogging System (September 19, 2018)
  • K081647 — ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS (August 12, 2008)
  • K063587 — XODUS MEDICAL ANTI-FOG SOLUTION (January 9, 2007)
  • K053433 — CAUTERY TIP CLEANER, MODEL 30500 (January 19, 2006)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)

Other clearances for product code DWJ

  • K252861 — Warming System (April 7, 2026)
  • 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)
  • 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)