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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K250700
Device Name Pen Injector Needle 32.5
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku, Tokyo,  JP 151-0072
Applicant Contact Brian Byrd
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Brian Byrd
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/07/2025
Decision Date 11/21/2025
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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