YKD SpO2 Sensor Receives FDA 510(k) Clearance, ECG Cable Registered with FDA

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.

FDA Registration of YKD ECG Cable with Leadwires

In addition to the SpO2 sensor clearance, YKD has registered its ECG cable with leadwires with the U.S. FDA. The relevant registration information includes:

  • Device Name: CABLE, ELECTRODE
  • Registration Number: 3013436124
  • FEI Number: 3013436124
  • Owner/Operator Number: 10089496

It is important to distinguish FDA establishment registration and device listing from 510(k) clearance. The CSS032D SpO2 Sensor has a specific 510(k) clearance under K251751, while the ECG cable is referenced here through its FDA registration information.

This distinction provides customers with a clearer view of the regulatory status of each product when conducting supplier qualification and regulatory reviews.

What These FDA Milestones Mean for Medical Device Customers

For medical device distributors and OEM manufacturers, regulatory status is one part of a broader supplier evaluation process.

Customers also need to consider product compatibility, manufacturing consistency, quality systems, customization capabilities, technical support, and supply continuity.

YKD’s FDA regulatory progress provides additional support for customers looking for a medical accessory supplier with experience in international markets.

For Medical Device Distributors

YKD’s FDA-cleared SpO2 sensor can be evaluated alongside product specifications, compatibility information, regulatory documentation, and OEM support when developing or expanding a patient monitoring accessory portfolio.

For OEM and Private-Label Projects

YKD provides OEM/ODM services for medical accessories, including customized product configurations, connectors, cable lengths, labeling, and packaging according to project requirements.

For Medical Equipment Manufacturers

YKD supplies ECG cables, SpO2 sensors, temperature probes, NIBP accessories, and other patient monitoring components designed for use with a wide range of medical equipment.

YKD’s Experience in Patient Monitoring Accessories

Regulatory compliance is supported by a broader manufacturing and quality management system.

Since 2008, YKD has specialized in the development and production of medical accessories for patient monitoring and diagnostic equipment. Its product portfolio includes SpO2 sensors, ECG/EKG cables and lead wires, temperature probes, NIBP accessories, EEG accessories, and other medical cable assemblies.

YKD works with distributors, medical equipment manufacturers, and OEM customers across international markets, providing support from product selection and compatibility confirmation through sampling, customization, production, and delivery.

This experience is particularly valuable for customers who require medical accessories beyond standard catalog products.

SpO2 Sensors and ECG Cables for Different Applications

YKD’s SpO2 sensor portfolio includes reusable and disposable configurations designed for different patient monitoring applications.

The company also develops and manufactures ECG cables and lead wires in different lead configurations, connectors, cable lengths, and patient applications.

Depending on customer requirements, available solutions may include:

  • Reusable SpO2 sensors
  • Disposable SpO2 sensors
  • SpO2 adapter and extension cables
  • ECG/EKG cables and lead wires
  • Adult and pediatric configurations
  • Customized connectors and cable lengths
  • OEM labeling and packaging
  • Product sampling and small-batch development

Product compatibility should be confirmed according to the specific patient monitor, connector type, pin configuration, lead configuration, and intended application.

Supporting a More Reliable Medical Accessory Supply Chain

For international medical device companies, selecting a supplier involves more than comparing product prices.

Regulatory documentation, manufacturing capability, product consistency, technical communication, customization, and supply continuity all contribute to a reliable long-term supplier relationship.

The FDA 510(k) clearance of the CSS032D SpO2 Sensor and the FDA registration of YKD’s ECG cable with leadwires represent another step in YKD’s ongoing development of its regulatory and manufacturing capabilities for international markets.

For distributors, OEM manufacturers, and medical equipment companies sourcing SpO2 sensors, ECG cables, or customized patient monitoring accessories, YKD provides product information, compatibility support, samples, and OEM/ODM solutions.

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