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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 / K250793

510(k) cleared

RhythmStar System (SL)

RhythMedix, LLC · Apr 21, 2026 · K250793

FDA cleared the RhythmStar System (SL) from RhythMedix, LLC on Apr 21, 2026 under K250793, a traditional 510(k). The device falls under product code QYX, Outpatient Cardiac Telemetry, regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 14, 2025. The decision came 403 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 RhythMedix, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250793?

K250793 is the FDA 510(k) for RhythmStar System (SL), submitted by RhythMedix, LLC. FDA's decision date was Apr 21, 2026, under product code QYX (Outpatient Cardiac Telemetry).

Who makes the RhythmStar System (SL)?

RhythMedix, LLC, based in Mt. Laurel, NJ, is the applicant of record for K250793.

How long did the K250793 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Apr 21, 2026, 403 days later.

← All decisions in April 2026