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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K253510
Device Name Freestyle Mini Hands-free
Applicant
Medela, LLC
1101 Corporate Dr.
Mchenry,  IL  60050
Applicant Contact Jenni Vescovo
Correspondent
Medela, LLC
1101 Corporate Dr.
Mchenry,  IL  60050
Correspondent Contact Jenni Vescovo
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/05/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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