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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 / April 2026 / K252810

510(k) cleared

FloPatch FP120

Flosonics Medical · Apr 24, 2026 · K252810

FDA cleared the FloPatch FP120 from Flosonics Medical on Apr 24, 2026 under K252810, a special 510(k). The device falls under product code DPW, Flowmeter, Blood, Cardiovascular, regulated at 21 CFR 870.2100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 3, 2025. The decision came 233 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 Flosonics Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252810?

K252810 is the FDA 510(k) for FloPatch FP120, submitted by Flosonics Medical. FDA's decision date was Apr 24, 2026, under product code DPW (Flowmeter, Blood, Cardiovascular).

Who makes the FloPatch FP120?

Flosonics Medical, based in Toronto, is the applicant of record for K252810.

How long did the K252810 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Apr 24, 2026, 233 days later.

← All decisions in April 2026