Cleared Traditional

DuoprossTM Smart Cap (Type I)

K252518 · Duopross Meditech Corporate · General Hospital

Dec 2025

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K252518 is an FDA 510(k) clearance for the DuoprossTM Smart Cap (Type I), a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Duopross Meditech Corporate (Farmingdale, US). The FDA issued a Cleared decision on December 17, 2025, 128 days after receiving the submission on August 11, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K252518 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2025
Decision Date	December 17, 2025
Days to Decision	128 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF