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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K252015
Device Name FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
Applicant
Koru Medical Systems, Inc.
100 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Emily DiMambro
Correspondent
Koru Medical Systems, Inc.
100 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Emily DiMambro
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   PKP  
Date Received06/27/2025
Decision Date 01/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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