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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 / July 2026 / K261082

510(k) cleared

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)

Microlife Corporation · Jul 23, 2026 · K261082

FDA cleared the Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) from Microlife Corporation on Jul 23, 2026 under K261082, a traditional 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 1, 2026. The decision came 113 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Microlife Corporation has one other decision in the tracker over the last 12 months: K253180 (Microlife Digital Peak Flow Meter, Model PF200B (PF200B)).

Questions & Answers

What did FDA clear under K261082?

K261082 is the FDA 510(k) for Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G), submitted by Microlife Corporation. FDA's decision date was Jul 23, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)?

Microlife Corporation, based in Taipei, is the applicant of record for K261082.

How long did the K261082 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jul 23, 2026, 113 days later.

← All decisions in July 2026

Sources