Shenzhen YKD Technology Co., Ltd. has reached an important regulatory milestone in the U.S. market with the FDA 510(k) clearance of its CSS032D SpO2 Sensor and the FDA registration of its ECG cable with leadwires.
For YKD, these developments represent more than regulatory documentation. They support the company’s continued efforts to provide reliable patient monitoring accessories for medical device distributors, OEM customers, and healthcare equipment manufacturers worldwide.
FDA 510(k) Clearance for YKD CSS032D SpO2 Sensor
On December 19, 2025, the U.S. Food and Drug Administration (FDA) issued 510(k) clearance for YKD’s CSS032D SpO2 Sensor under 510(k) Number K251751.
The FDA database identifies the device as a Class II medical device under 21 CFR 870.2700 – Oximeter, with Product Code DQA.
Key regulatory information includes:
- Trade/Device Name: SpO2 Sensor CSS032D
- 510(k) Number: K251751
- Regulation Number: 21 CFR 870.2700
- Regulation Name: Oximeter
- Regulatory Class: Class II
- Product Code: DQA
- FDA Decision Date: December 19, 2025
The FDA 510(k) process evaluates whether a medical device is substantially equivalent to a legally marketed predicate device for its intended use and technological characteristics.
For distributors and OEM customers, this clearance provides an important regulatory reference when evaluating YKD’s CSS032D SpO2 Sensor for the U.S. market.
