Vapotherm® gets FDA 510(k)

Vapotherm® Announces FDA 510(k) Clearance for the All Patient Circuit™, Enabling High Velocity Therapy for Neonatal to Adult Patients

April 21, 2026
10:15 pm

EXETER, N.H., April 21, 2026 /PRNewswire/ -- Vapotherm, Inc., a developer and manufacturer of advanced respiratory technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its All Patient Circuit (APC™) which now includes therapy settings for neonatal and infant patients. The cleared APC enables the HVT 2.0 high velocity therapy system to deliver therapy across a 2–45 L/min flow range using a single disposable patient circuit.

The APC will be available in both standard and aerosol configurations and is designed to support clinicians in treating a broad range of patients with one circuit, helping to simplify setup, streamline workflows, and reduce the need to change circuits as patient needs evolve.

“FDA clearance of the All Patient Circuit represents an important advancement for both clinicians and patients,” said Joe Army, President and CEO of Vapotherm. “By enabling HVT 2.0 to support neonatal to adult patients with a single disposable circuit, we are helping healthcare teams deliver high velocity therapy more efficiently while maintaining the comfort and noninvasive approach Vapotherm is known for.”

The APC is designed for use with the HVT 2.0 platform to deliver optimally conditioned breathable gases across patient populations and care settings. The availability of a single circuit capable of spanning from neonatal to adult patients may help reduce clinical complexity while supporting continuity of therapy.

Vapotherm® Announces FDA 510(k) Clearance for the All Patient Circuit™, Enabling High Velocity Therapy for Neonatal to Adult Patients

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