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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Device Disinfectant
510(k) Number K252006
Device Name OTTO™ Disinfecting Cap
Applicant
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact Nichelle Cato
Correspondent
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact Nichelle Cato
Regulation Number880.5440
Classification Product Code
QBP  
Date Received06/27/2025
Decision Date 03/27/2026
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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