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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 / K252839

510(k) cleared

ZywieZ3 Sensor & Adhesive

Zywie, Inc. · Jun 18, 2026 · K252839

FDA cleared the ZywieZ3 Sensor & Adhesive from Zywie, Inc. on Jun 18, 2026 under K252839, a traditional 510(k). The device falls under product code MWJ, Electrocardiograph, Ambulatory (Without Analysis), regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 5, 2025. The decision came 286 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 Zywie, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252839?

K252839 is the FDA 510(k) for ZywieZ3 Sensor & Adhesive, submitted by Zywie, Inc.. FDA's decision date was Jun 18, 2026, under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)).

Who makes the ZywieZ3 Sensor & Adhesive?

Zywie, Inc., based in Johns Creek, GA, is the applicant of record for K252839.

How long did the K252839 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Jun 18, 2026, 286 days later.

← All decisions in June 2026