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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 / June 2026 / K253088

510(k) cleared

OneStim-DUO Cardiac Stimulator (MP5003-4CO)

Micropace Pty, Ltd. · Jun 12, 2026 · K253088

FDA cleared the OneStim-DUO Cardiac Stimulator (MP5003-4CO) from Micropace Pty, Ltd. on Jun 12, 2026 under K253088, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 23, 2025. The decision came 262 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 Micropace Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253088?

K253088 is the FDA 510(k) for OneStim-DUO Cardiac Stimulator (MP5003-4CO), submitted by Micropace Pty, Ltd.. FDA's decision date was Jun 12, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

Micropace Pty, Ltd., based in Homebush W., is the applicant of record for K253088.

How long did the K253088 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Jun 12, 2026, 262 days later.

← All decisions in June 2026