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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 / May 2026 / K252859

510(k) cleared

ZEUS Platform (FG0501US)

iRhythm Technologies, Inc. · May 29, 2026 · K252859

FDA cleared the ZEUS Platform (FG0501US) from iRhythm Technologies, Inc. on May 29, 2026 under K252859, 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 9, 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 iRhythm Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252859?

K252859 is the FDA 510(k) for ZEUS Platform (FG0501US), submitted by iRhythm Technologies, Inc.. FDA's decision date was May 29, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the ZEUS Platform (FG0501US)?

iRhythm Technologies, Inc., based in San Francisco, CA, is the applicant of record for K252859.

How long did the K252859 review take?

FDA received the submission on Sep 9, 2025 and issued its decision on May 29, 2026, 262 days later.

← All decisions in May 2026