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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 / K252389

510(k) cleared

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

Smwmed, Inc. · Apr 23, 2026 · K252389

FDA cleared the Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) from Smwmed, Inc. on Apr 23, 2026 under K252389, a traditional 510(k). The device falls under product code DSH, Recorder, Magnetic Tape, Medical, regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 31, 2025. The decision came 266 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 Smwmed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252389?

K252389 is the FDA 510(k) for Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX), submitted by Smwmed, Inc.. FDA's decision date was Apr 23, 2026, under product code DSH (Recorder, Magnetic Tape, Medical).

Who makes the Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)?

Smwmed, Inc., based in San Diego, CA, is the applicant of record for K252389.

How long did the K252389 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Apr 23, 2026, 266 days later.

← All decisions in April 2026