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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 K250724
Device Name Intraosseous Infusion Needles
Applicant
Spectrum Vascular
50 Main St.
Suite 1000
White Plains,  NY  10606
Applicant Contact Sharon Klugewicz
Correspondent
Spectrum Vascular
50 Main St.
Suite 1000
White Plains,  NY  10606
Correspondent Contact Sharon Klugewicz
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/10/2025
Decision Date 07/30/2025
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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