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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K262215
Device Name Profoject™ Safety Sliding Blood Collection Set
Applicant
CMT Health PTE., Ltd.
6001 Beach Rd., #19-13a, Golden Mile Tower
Singapore,  SG 199589
Applicant Contact Monica Ma
Correspondent
CMT Health PTE., Ltd.
6001 Beach Rd., #19-13a, Golden Mile Tower
Singapore,  SG 199589
Correspondent Contact Monica Ma
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received06/30/2026
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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