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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name peripheral blood processing device for wound management
510(k) Number BK251174
Tradename FastSkin Patch
Device Name Peripheral blood processing device for wound management
Original Applicant
MimiX Biotherapeutics, Ltd
aarbergstrasse 46, ch-2503
biel/bienne,  Canton of Bern,  2503, 
Regulation Number864.9245
Classification Product Code
PMQ  
Date Received02/28/2025
Decision Date 11/07/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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