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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 K252631
Device Name Profoject™ Disposable Needle
Applicant
CMT Health PTE., Ltd.
150 Beach Rd., #28-05
Gateway W.,  SG 189720
Applicant Contact Monica Ma
Correspondent
CMT Health PTE., Ltd.
150 Beach Rd., #28-05
Gateway W.,  SG 189720
Correspondent Contact Monica Ma
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/20/2025
Decision Date 10/16/2025
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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