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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 / September 2025 / K250837

510(k) cleared

Pulse Oximeter

Shanghai Berry Electronic Tech Co., Ltd. · Sep 25, 2025 · K250837

FDA cleared the Pulse Oximeter from Shanghai Berry Electronic Tech Co., Ltd. on Sep 25, 2025 under K250837, 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 Mar 20, 2025. The decision came 189 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 Shanghai Berry Electronic Tech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250837?

K250837 is the FDA 510(k) for Pulse Oximeter, submitted by Shanghai Berry Electronic Tech Co., Ltd.. FDA's decision date was Sep 25, 2025, under product code DQA (Oximeter).

Who makes the Pulse Oximeter?

Shanghai Berry Electronic Tech Co., Ltd., based in Shanghai, is the applicant of record for K250837.

How long did the K250837 review take?

FDA received the submission on Mar 20, 2025 and issued its decision on Sep 25, 2025, 189 days later.

← All decisions in September 2025