# DEN170001: Precision Flow® HVNI

- Pathway: De Novo (Direct)
- Applicant: Vapotherm, Inc.
- Decided: Apr 10, 2018 after 462 days
- Product code: QAV (High Flow/High Velocity Humidified Oxygen Delivery Device)
- Device class: 2
- Regulation: 21 CFR 868.5454
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K221338: F&P Airvo 3 (2023), 2 descendants of its own
- K233643: F&P Airvo 3 NIV (PT311US) (2024), 1 descendant of its own
- K242931: HFT750U (2025), 0 descendants of its own
- K221318: HVT 2.0 (2022), 0 descendants of its own

## Indications for use
Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.

Source page: https://510kreport.com/device/DEN170001
Methodology: https://510kreport.com/methodology