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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 / October 2025 / DEN240074

510(k) cleared

Pulsenmore ES

Pulsenmore, Ltd. · Oct 31, 2025 · DEN240074 · In the directory

FDA cleared the Pulsenmore ES from Pulsenmore, Ltd. on Oct 31, 2025 under DEN240074, a direct 510(k). The device falls under product code SGJ, Ultrasound Imaging System For Acquiring Images At Home By Lay Users, regulated at 21 CFR 892.1590 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 11, 2024. The decision came 324 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 Pulsenmore, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN240074?

DEN240074 is the FDA 510(k) for Pulsenmore ES, submitted by Pulsenmore, Ltd.. FDA's decision date was Oct 31, 2025, under product code SGJ (Ultrasound Imaging System For Acquiring Images At Home By Lay Users).

Who makes the Pulsenmore ES?

Pulsenmore, Ltd., based in Omer, is the applicant of record for DEN240074. The company is listed in the MedDevice Startups directory.

How long did the DEN240074 review take?

FDA received the submission on Dec 11, 2024 and issued its decision on Oct 31, 2025, 324 days later.

← All decisions in October 2025