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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K254094
Device Name Endox High Level Disinfectant
Applicant
Whiteley USA, Inc.
251 Little Falls Dr.
Wilmington,  DE  19808
Applicant Contact Darran Leyden
Correspondent
Whiteley USA, Inc.
251 Little Falls Dr.
Wilmington,  DE  19808
Correspondent Contact Carys Lonsdale
Regulation Number880.6885
Classification Product Code
MED  
Date Received12/19/2025
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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