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# Vapotherm Ventilator Cleared for Expanded Use
- URL: https://www.fdaweb.com/vapotherm-ventilator-cleared-for-expanded-use/
- Published: 2018-10-09T12:00:00.000Z
- Updated: 2026-09-15T00:37:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142542

FDA has cleared a Vapotherm 510(k) for the latest version of its Precision Flow Hi-VNI system, which includes a new product category and product code (QAV). The agency also granted an expanded indication for the device — to augment breathing of spontaneously breathing patients suffering from respiratory distress in a hospital setting. “This patient population is similar to that treated by other forms of non-invasive ventilation, making the Precision Flow Hi-VNI system a viable alternative to Non-invasive Positive Pressure Ventilation (NiPPV) for most patients,” the company says. The clearances were based on clinical data showing that the Hi-VNI technology can safely and effectively be used in treating undifferentiated respiratory distress in patients, ranging from newborns to adults, it adds.