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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K260903
Device Name Hot Pink Pad Warming System
Applicant
Xodus Medical, Inc.
702 Prominence Dr.
New Kensington,  PA  15068
Applicant Contact Paul Lloyd
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/18/2026
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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