Vapotherm Gains FDA Clearance for All Patient Circuit Device

Exeter, New Hampshire, USA, April 20, 2026

In a significant advancement in respiratory medical device innovation, Vapotherm, Inc. has announced that it has received U.S. FDA 510(k) clearance for its All Patient Circuit™ (APC™), expanding the capabilities of its HVT 2.0 high velocity therapy system to support neonatal, pediatric, and adult patients using a single disposable circuit. This regulatory milestone underscores Vapotherm’s commitment to delivering noninvasive respiratory support solutions that improve clinical efficiency and patient outcomes across diverse care settings. The newly cleared APC enables therapy delivery across a broad flow range of 2–45 L/min, making it a versatile solution for treating patients with acute and chronic respiratory conditions.

Single Circuit Innovation Enhances Clinical Efficiency

The introduction of the All Patient Circuit™ represents a major step forward in simplifying respiratory therapy workflows in hospitals and critical care environments. Traditionally, clinicians must switch between multiple circuits to accommodate different patient populations, increasing complexity and potential delays in care. With the APC, Vapotherm provides a single, universal disposable circuit that can be used across neonatal to adult patients, significantly reducing the need for equipment changes.

This innovation supports streamlined clinical workflows, reduced setup time, and improved operational efficiency, particularly in high-pressure environments such as intensive care units (ICUs) and emergency departments. By minimizing circuit changes, healthcare providers can focus more on patient care while maintaining consistent therapy delivery.

Expanded High Velocity Therapy Across Patient Populations

The FDA-cleared APC enhances the functionality of Vapotherm’s HVT 2.0 platform, a system designed to deliver optimally conditioned breathable gases in a mask-free, noninvasive manner. High Velocity Therapy (HVT) has gained recognition for its ability to provide effective respiratory support while improving patient comfort, making it particularly valuable for patients who cannot tolerate traditional ventilation methods.

With the inclusion of neonatal and infant therapy settings, the APC now enables clinicians to deliver continuous respiratory support across all age groups, ensuring continuity of care as patient needs evolve. The availability of both standard and aerosol-compatible configurations further expands its clinical utility, allowing integration with aerosol drug delivery systems when needed.

Regulatory Milestone Strengthens MedTech Innovation

The FDA’s 510(k) clearance validates the safety and performance of Vapotherm’s APC, reinforcing its position in the medical technology (MedTech) sector. This approval reflects growing demand for scalable, patient-centric respiratory solutions that align with modern healthcare needs, including efficiency, adaptability, and improved patient experience.

Vapotherm’s technology has already been used to treat millions of patients worldwide, and the addition of the APC further strengthens its portfolio of advanced respiratory care devices. As healthcare systems continue to prioritize noninvasive therapies and workflow optimization, innovations like the All Patient Circuit are expected to play a critical role in shaping the future of respiratory care delivery.

Overall, Vapotherm’s FDA clearance for the All Patient Circuit™ marks a pivotal advancement in respiratory medical devices, offering a versatile, efficient, and patient-friendly solution for delivering high velocity therapy across all age groups. By combining regulatory success, engineering innovation, and clinical practicality, Vapotherm continues to drive progress in modern respiratory care, supporting better outcomes and enhanced experiences for both patients and healthcare providers.

Source: Vapotherm press release