510(k) K252518

DuoprossTM Smart Cap (Type I) by Duopross Meditech Corporate — Product Code FMF

K252518 is an FDA 510(k) premarket notification submitted by Duopross Meditech Corporate for the device "DuoprossTM Smart Cap (Type I)". The FDA issued a decision of Substantially Equivalent on December 17, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2025
Date Received
August 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type