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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 / December 2025 / K251143

510(k) cleared

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)

Ningbo Ranor Medical Science & Technology Co., Ltd. · Dec 19, 2025 · K251143

FDA cleared the Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) from Ningbo Ranor Medical Science & Technology Co., Ltd. on Dec 19, 2025 under K251143, 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 14, 2025. The decision came 249 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ningbo Ranor Medical Science & Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253142 (Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)).

Questions & Answers

What did FDA clear under K251143?

K251143 is the FDA 510(k) for Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L), submitted by Ningbo Ranor Medical Science & Technology Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)?

Ningbo Ranor Medical Science & Technology Co., Ltd., based in Ningbo, is the applicant of record for K251143.

How long did the K251143 review take?

FDA received the submission on Apr 14, 2025 and issued its decision on Dec 19, 2025, 249 days later.

← All decisions in December 2025

Sources