Oxygen concentrators are critical medical devices used to deliver purified oxygen to patients with respiratory conditions. To ensure safety, efficacy, and compliance with global standards, these devices must obtain specific certifications. This guide explores the mandatory and voluntary certifications for oxygen concentrators, their importance, and how to verify them.

Why Certifications Matter for Oxygen Concentrators

Certifications serve as proof that a device meets regulatory, safety, and performance benchmarks. For oxygen concentrators, certifications:

• Ensure patient safety by validating oxygen purity and electrical safety.
• Guarantee compliance with regional regulations (e.g., FDA in the U.S., CE in Europe).
• Build trust among healthcare providers and end-users.

Without proper certifications, devices may pose risks like incorrect oxygen delivery or electrical hazards.

Mandatory Certifications for Oxygen Concentrators

1. FDA Approval (U.S. Market)

The U.S. Food and Drug Administration (FDA) regulates oxygen concentrators as Class II medical devices. Manufacturers must submit a 510(k) premarket notification to demonstrate their product is “substantially equivalent” to a legally marketed device.

Key FDA Requirements:

• Biocompatibility testing for materials.
• Electrical safety (e.g., IEC 60601-1 standard).
• Clinical performance data proving oxygen output (e.g., 87–99% purity).

FDA Medical Device Classification

2. CE Marking (European Union)

In the EU, oxygen concentrators require CE Marking under the Medical Device Regulation (MDR) 2017/745. This certification confirms compliance with health, safety, and environmental standards.

Steps to Obtain CE Marking:

• Conduct a risk assessment per ISO 14971.
• Perform clinical evaluations.
• Work with a Notified Body for audits.

EU MDR Compliance Guide

Voluntary Certifications and Standards

1. ISO 13485:2016

This international standard focuses on quality management systems (QMS) for medical device manufacturers. While not mandatory, ISO 13485 certification is often required by regulators and distributors.

Benefits:

• Streamlined regulatory approvals.
• Enhanced manufacturing consistency.
• Improved supplier credibility.

2. UL Certification

Underwriters Laboratories (UL) provides safety certifications for electrical components. A UL Listing ensures the device meets U.S. and Canadian electrical safety standards.

How to Verify Certifications

1. Check the Product Label: Look for FDA clearance numbers, CE marks, or ISO certifications.
2. Request Documentation: Manufacturers must provide conformity certificates.
3. Search Regulatory Databases:
   • FDA’s 510(k) Database
   • EU’s European Database on Medical Devices (EUDAMED)

FDA 510(k) Database

Consequences of Non-Compliance

Uncertified oxygen concentrators may:

• Be confiscated by customs.
• Void manufacturer warranties.
• Expose users to legal liabilities.

In 2025, the FDA issued warnings to 12 companies selling uncertified oxygen concentrators during the COVID-19 pandemic.

Final Thoughts

Certifications like FDA approval, CE Marking, and ISO 13485 are non-negotiable for oxygen concentrators. Always verify certifications through official channels and prioritize devices from reputable manufacturers.