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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 / February 2026 / K252805

510(k) cleared

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Feb 17, 2026 · K252805

FDA cleared the YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. on Feb 17, 2026 under K252805, a traditional 510(k). The device falls under product code DQA, Oximeter, regulated at 21 CFR 870.2700 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 3, 2025. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261571 (Manual Wheelchair (H008, PCK7)), K252779 (YUWELL® Electronic Blood Pressure Monitor (YE630CR)), K253228 (YUWELL® Electronic Blood Pressure Monitor (YE650AR)).

Questions & Answers

What did FDA clear under K252805?

K252805 is the FDA 510(k) for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310), submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. FDA's decision date was Feb 17, 2026, under product code DQA (Oximeter).

Who makes the YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)?

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., based in Danyang, is the applicant of record for K252805.

How long did the K252805 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Feb 17, 2026, 167 days later.

← All decisions in February 2026

Sources