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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 / September 2025 / K250922

510(k) cleared

Edema Guard Monitor (EGM) CardioSet-001

Cardioset Medical , Ltd. · Sep 9, 2025 · K250922

FDA cleared the Edema Guard Monitor (EGM) CardioSet-001 from Cardioset Medical , Ltd. on Sep 9, 2025 under K250922, a traditional 510(k). The device falls under product code DSB, Plethysmograph, Impedance, regulated at 21 CFR 870.2770 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 27, 2025. The decision came 166 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 Cardioset Medical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250922?

K250922 is the FDA 510(k) for Edema Guard Monitor (EGM) CardioSet-001, submitted by Cardioset Medical , Ltd.. FDA's decision date was Sep 9, 2025, under product code DSB (Plethysmograph, Impedance).

Who makes the Edema Guard Monitor (EGM) CardioSet-001?

Cardioset Medical , Ltd., based in Matan, is the applicant of record for K250922.

How long did the K250922 review take?

FDA received the submission on Mar 27, 2025 and issued its decision on Sep 9, 2025, 166 days later.

← All decisions in September 2025