September 2026 — Oxytek Medical Technology Co., Ltd. is pleased to announce that its portable oxygen concentrators, OX-1B and OX-1A-E, have received FDA 510(k) clearance, marking an important milestone in the company’s continued expansion of its portable oxygen therapy product portfolio and presence in the U.S. market.

The FDA 510(k) clearance confirms that the two portable oxygen concentrators have completed the applicable FDA premarket review pathway for their device category. Portable oxygen concentrators are regulated by the FDA under 21 CFR 868.5440, Product Code CAW.

Two Portable Solutions for Different Market Needs

The OX-1B and OX-1A-E were developed to provide compact and convenient oxygen therapy solutions while addressing different market and user requirements.

The OX-1A-E is designed as a lightweight portable oxygen concentrator with a focus on portability, ease of use, and reliable oxygen delivery. Its compact design makes it suitable for users who need greater flexibility in daily oxygen therapy.

The OX-1B further expands Oxytek’s portable oxygen concentrator offering, with a practical design focused on serviceability, flexibility, and long-term use. The removable battery and replaceable oxygen-generation components provide additional convenience for distributors and service providers in markets where maintenance and after-sales support are important considerations.

Both models are designed around the needs of the growing home-care and portable oxygen therapy market, providing distributors, healthcare providers, and oxygen therapy brands with additional options for different market segments.

Expanding Oxytek’s FDA-Cleared Product Portfolio

The FDA clearance of the OX-1B and OX-1A-E follows Oxytek’s continued investment in international regulatory compliance and product development.

With these two portable models now cleared for the U.S. market, Oxytek is further strengthening its product portfolio across both stationary and portable oxygen concentrators.

The company’s U.S. regulatory portfolio now includes the OX-5A and OX-5C 5-liter oxygen concentrators, which received FDA 510(k) clearance in May 2026, in addition to the newly cleared OX-1B and OX-1A-E portable oxygen concentrators.

This expanded portfolio enables Oxytek to support a broader range of applications and business models, including homecare, DME, oxygen therapy brands, distributors, rental providers, and OEM/private-label programs.

Supporting Global Partners with Regulatory-Ready Products

For international distributors and healthcare companies, regulatory compliance is an increasingly important factor when selecting a long-term manufacturing partner.

The FDA 510(k) clearance of the OX-1B and OX-1A-E demonstrates Oxytek’s continued commitment to meeting the regulatory and quality requirements of major international markets.

Oxytek will continue to invest in product development, regulatory compliance, manufacturing capabilities, and after-sales support to provide reliable oxygen therapy solutions for global partners.

With the addition of the OX-1B and OX-1A-E, Oxytek is ready to work with more U.S. and international partners seeking reliable, flexible, and regulatory-compliant portable oxygen concentrator solutions.

About Oxytek Medical Technology

Oxytek Medical Technology Co., Ltd. specializes in the development and manufacturing of oxygen concentrators, with a product portfolio covering portable and stationary oxygen concentrators.

The company is committed to providing reliable oxygen therapy solutions for healthcare providers, distributors, homecare companies, and oxygen therapy brands worldwide.

For partnership, distribution, OEM, and private-label opportunities, please contact the Oxytek Medical team.