WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252518

510(k) cleared

DuoprossTM Smart Cap (Type I)

Duopross Meditech Corporate · Dec 17, 2025 · K252518

FDA cleared the DuoprossTM Smart Cap (Type I) from Duopross Meditech Corporate on Dec 17, 2025 under K252518, a traditional 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 11, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Duopross Meditech Corporate in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252518?

K252518 is the FDA 510(k) for DuoprossTM Smart Cap (Type I), submitted by Duopross Meditech Corporate. FDA's decision date was Dec 17, 2025, under product code FMF (Syringe, Piston).

Who makes the DuoprossTM Smart Cap (Type I)?

Duopross Meditech Corporate, based in Farmingdale, NY, is the applicant of record for K252518.

How long did the K252518 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Dec 17, 2025, 128 days later.

← All decisions in December 2025