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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 / K251751

510(k) cleared

Spo2 Sensor CSS032D

Shenzhen Ykd Technology Co., Ltd. · Dec 19, 2025 · K251751

FDA cleared the Spo2 Sensor CSS032D from Shenzhen Ykd Technology Co., Ltd. on Dec 19, 2025 under K251751, 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 Jun 9, 2025. The decision came 193 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 Shenzhen Ykd Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251751?

K251751 is the FDA 510(k) for Spo2 Sensor CSS032D, submitted by Shenzhen Ykd Technology Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code DQA (Oximeter).

Who makes the Spo2 Sensor CSS032D?

Shenzhen Ykd Technology Co., Ltd., based in Shenzhen, is the applicant of record for K251751.

How long did the K251751 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Dec 19, 2025, 193 days later.

← All decisions in December 2025