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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 / K261074

510(k) cleared

BIOMONITOR IV (471155)

Biotronik, Inc. · May 1, 2026 · K261074

FDA cleared the BIOMONITOR IV (471155) from Biotronik, Inc. on May 1, 2026 under K261074, a special 510(k). The device falls under product code MXD, Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 1, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Biotronik, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261074?

K261074 is the FDA 510(k) for BIOMONITOR IV (471155), submitted by Biotronik, Inc.. FDA's decision date was May 1, 2026, under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)).

Who makes the BIOMONITOR IV (471155)?

Biotronik, Inc., based in Lake Oswego, OR, is the applicant of record for K261074.

How long did the K261074 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on May 1, 2026, 30 days later.

← All decisions in May 2026