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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K252398
Device Name SURFLO Hybria Closed System Safety IV Catheter
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
M4-9-5, Hangzhou Economic & Technological Development Zone
Hangzhou,  CN 310018
Applicant Contact Tien Trinh
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Tien Trinh
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/31/2025
Decision Date 12/17/2025
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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